5/19/23, 5:58 PM MD - Medical Devices

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

601 IMP/IVD/2019/000424 M/S. Autocal-The AUTOCAL multicalibrator has been designed for the CDSCO Class B
MEDSOURCE calibration of HUMAN clinical chemistry reagents on preferably
OZONE HUMAN analysers.,Iron TPTZ liquicolor-The IRON TPTZ liquicolor
BIOMEDICALS has been designed for the quantitative determination of the iron
PVT LTD concentration in human serum or heparinised plasma.,alpha-Amylase
liquicolor-alpha-AMYLASE liquicolor multipurpose reagents have been
designed for the quantitative determination of alpha-amylase in
human serum and heparinised plasma,Alkaline Phosphatase
liquicolor-Alkaline Phosphatase (AP) opt. liquicolor has been designed
for the quantitative determination of alkaline phosphatase (AP) in
human serum and heparinised plasma.,LDH liquiUV-LDH liquiUV has
been designed for the quantitative determination of LDH in human
serum and plasma (heparinized and EDTA-plasma).,gamma-GT
liquicolor M - Test-Gamma-GT liquicolor has been designed for the
quantitative determination of Gamma-GT (L-Gamma-glutamyl
transferase) in human serum and EDTA-plasma.,GPT(ALAT) IFCC
mod. liquiUV-GPT (ALAT) IFCC mod. liquiUV has been designed for
the quantitative determination of GPT (alanine aminotransferase) in
human serum and plasma (heparinised and EDTA-
plasma).,GOT(ASAT) IFCC mod. liquiUV-GOT (ASAT) IFCC mod.
liquiUV has been designed for the quantitative determination of GOT
(aspartate aminotransferase) in human serum and plasma
(heparinised and EDTA-plasma).,Triglycerides liquicolor-
TRIGLYCERIDES liquicolormono has been designed for the
quantitative determination of triglycerides in human serum, EDTA-
plasma and heparinised plasma,Uric Acid liquicolor-URIC ACID
liquicolor has been designed for the quantitative determination of uric
acid in human serum, heparinised or EDTA plasma and
urine.,Glucose liquicolor-GLUCOSE liquicolor has been designed for
the quantitative determination of glucose in human whole blood ,
serum and plasma.,LDL Cholesterol liquicolor-LDL-CHOLESTEROL
liquicolor reagent has been designed for the quantitative
determination of LDL cholesterol in human serum.,Pancreas-Amylase
liquicolor-Pancreas-Amylase liquicolor test has been designed for the
quantitative determination of the Pancreas-Amylase activity in human
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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
serum.,Lipase liquicolor-LIPASE liquicolor has been designed for the
quantitative determination of the lipase activity in human
serum.,Rheumatoid Factors-RHEUMATOID FACTORS (RF)
turbidimetric test has been designed for the quantitative determination
of rheumatoid factors (RF) in human serum.,Anti-Streptolysin-O-The
HUMAN Anti-STREPTOLYSIN-O (ASO) latex-enhanced turbidimetric
test has been designed for the quantitative determination of anti-
streptolysin-O (ASO) in human serum.,HDL Cholesterol liquicolor-
HDL-CHOLESTEROL liquicolor reagent has been designed for the
quantitative determination of HDL cholesterol in human
serum.,Cholesterol liquicolor-CHOLESTEROL liquicolor test has been
designed for the quantitative determination of cholesterol in human
serum, EDTA-plasma and heparinised plasma.,Glycohaemoglobin
HbA1 Test-GLYCOHEMOGLOBIN HbA1 test has been designed for
the quantitative determination of HbA1 in human EDTA-
blood.,Albumin liquicolor-Photometric Colorimetric Test for Albumin
BCG-Method,Iron liquicolor-IRON liquicolor test has been designed
for the quantitative determination of ionized iron in human serum and
heparinised plasma.,25-OH Vitamin D-ELISA for the quantitative
measurement of 25-OH Vitamin D in human serum.,TSH ELISA-
HUMAN TSH ELISA has been designed as a sandwich ELISA test for
the quantitative determination of thyreotropin (TSH) in human
serum.,Calcium liquicolor-The calcium liquicolor test has been
designed for the quantitative determination of ionized calcium in
human serum and heparinised plasma.,Magnesium liquicolor-
MAGNESIUM liquicolor has been designed for the quantitative
determination of ionized magnesium in human serum and plasma
(except EDTA-plasma).,Complement C4-The C3/C4/TRF Standard is
used for calibration of the immunoturbidimetric complement C3/C4
and transferrin assays.,Calibrator for Hematology Analyzer-The HC-
CALIBRATOR has been designed for verification of precision and
accuracy of the HUMAN 3-and 5-part differential hematology
system.,HC5D-Control-HC5D-CONTROL is an assayed blood control
material intended for use in the verification of accuracy and precision
of HumaCount 5D providing white blood cell differentiation of 5-Part

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
WBC’s.,HC5D DILUENT-The HC5D CBC Diluent is intended to be
used with the HumaCount 5D analyzer for sample dilution and
preparation of cell suspension before running the samples.,HC5D
DIFF LYSE-The HC5D DIFF LYSE is intended to be used with the
HumaCount 5D analyzer for lysing the red blood cells, determining the
hemoglobin, white blood cell classification and counting the total
number of white blood cells.,HC5D Clean-The HC5D CBC Clean is
intended to be used with the HumaCount 5D analyzer for cleaning the
fluidic system of the analyzer and regular instrument cleaning.,HC5D
CBC LYSE-The HC5D CBC LYSE is intended to be used with the
HumaCount 5D analyzer for lysing the red blood cells and white blood
cell classification.,Imtec- ANA LIA MAXX-IMTEC-ANA-LIA Maxx
(ITC92005) has been designed as a line immuno assay (LIA) for the
detection of antinuclear antibody (ANA) profiles.,Imtec - Vasculitis LIA-
IMTEC-Vasculitis-LIA test (ITC82040) has been desigened as a line
immuno assay (LIA) for the detection of antibodies in autoimmune
vasculitis and Goodpasture's syndrome.,Imtec - Liver LIA S-The
IMTEC-Liver-LIA S test (ITC66205) has been designed as a line
immuno assay (LIA) for the detection of autoantibodies in autoimmune
liver diseases of different specificity.,Imtec Myositis-LIA PL-Myositis-
LIA PL test (ITC60201) has been designed as a line immunoassay
(LIA) for the detection of myositis-specific antibody (MSA) and
myositis-associated antibody (MAA) profiles.,Imtec- Gastro LIA-The
IMTEC-Gastro-LIA test (ITC30701) has been designed as a line
immuno assay (LIA) for the detection of antibodies in gastrointestinal
diseases of different specificity and subclasses (IgA and
IgG).,HumaTex ASO-HUMATEX ASO has been designed for the
qualitative and semi-quantitative determination of antibodies against
streptolysin O (ASO) in human serum.,HumaTex RF-HUMATEX RF
has been designed for the qualitative and semi-quantitative
determination of rheumatoid factors (RF) in human serum.,HumaTex
CRP-HUMATEX RF has been designed for the qualitative and semi-
quantitative determination of rheumatoid factors (RF) in human
serum.,I.M. Quick Test-IM QUICK TEST has been designed for the
qualitative detection of heterophilic antibodies associated with acute

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
infectious mononucleosis (IM) in human serum.,SLE Latex Test-SLE
LATEX TEST has been designed for the qualitative detection of auto
antibodies directed against deoxyribonucleo protein (DNP) associated
with systemic lupus erythematodes (SLE).,Reagent Pack HumaLyte
Plus 3-Reagent Pack for HumaLyte Plus3,Daily Cleaning Solution
Humalyte Plus-Daily Cleaning Solution for Humalyte Plus,HC-
Cleaner-Used to perform cleaning process of the fluidics.,HC-Lyse-
CF-Used to prepare blood hemolysate for WBC and HGB
measurement.,HC-Diluent-Isotonic saline solution, used to dilute
whole blood samples and to rinse the fluidic system between
measuring procedures.,Tip Cleaning Kit-The TIP CLEANING KIT for
HS600 has been designed for cleaning the neadles of the HumaStar
600.,Total Protein liquicolor-TOTAL PROTEIN liquicolor test has been
designed for the quantitative determination of inorganic Total Protein
in human serum.,T4 ELISA-The HUMAN T4 ELISA test has been
designed as a competitive ELISA test for the quantitative
determination of L-thyroxine (T4) in human serum or plasma (EDTA,
heparin).,T3 ELISA-The HUMAN T3 ELISA test has been designed as
a competitive ELISA test for the quantitative determination of T3 in
human serum or plasma (EDTA, heparin).,Combina 13-COMBINA 13
has been designed as urine test strips for the rapid determination of
urobilinogen, bilirubin, ketones, creatinine, hemoglobin/blood, protein,
microalbumin, nitrite, leucocytes, glucose, specific gravity, pH and
ascorbic acid.,Special Wash Solution-Special wash solution for
HumaStar 100 and 200,Cuvette Clean-The CUVETTE CLEAN for
automated analyzers has been designed for the cleaning of the
cuvettes after testing latex enhanced tests on automated
analyzers.,Wash Additive-The WASH ADDITIVE is used to prepare
the wash solution for HumaStar analyzers.,Serodos-SERODOS
control sera has been designed for control of precision and accuracy
of clinical chemistry methods both manual and automated.,CK-MB
Calibrator-CK-MB Control and CK-MB Calibrator sera have been
designed for control of precision and accuracy of CK-MB liquiUV
method both manual and automated.,CK-MB Control-CK-MB Control
and CK-MB Calibrator sera have been designed for control of

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
precision and accuracy of CK-MB liquiUV method both manual and
automated.,Serodos Plus-SERODOS Plus control sera has been
designed for control of precision and accuracy of clinical chemistry
methods both manual and automated.,TURBIDOS Control-The
TURBIDOS control sera have been designed for control of precision
and accuracy of clinical chemistry methods both manual and
automated.,CK MB liquiUV-CK-MB liquiUV has been designed for the
quantitative determination of CK-MB (Creatine kinase MB isoenzyme)
in human serum and plasma (heparinised and EDTA-
plasma).,Alkaline Phosphatase liquicolor IFCC-ALKALINE
PHOSPHATASE (AMP) IFCC liquicolor test has been designed for the
quantitative determination of alkaline phosphatase (AP) in human
serum and heparinised plasma.,CK NAC activated liquiUV-CK NAC-
act. liquiUV has been designed for the quantitative determination of
CK (Creatine kinase) in human serum and heparinised or EDTA
plasma.,CK-MB NAC-activated-The CK-MB NAC-act. test has been
designed for the quantitative determination of CK-MB (Creatine
kinase) in human serum and plasma (heparinised and EDTA-
plasma).,CK NAC activated-The CK NAC-act. HUMAZYM test has
been designed for the quantitative determination of CK (Creatine
kinase) in human serum and plasma (heparinized and EDTA-
plasma).,Ferritin Calibrator set-The Ferritin test has been designed for
the quantitative determination of ferritin in human serum.,Ferritin-The
Ferritin test has been designed for the quantitative determination of
ferritin in human serum.,Immunoglobulins direct IgM Reagent Kit-The
IMMUNOGLOBULINS direct IgA, IgG, IgM Multipurpose reagents
have been designed for the quantitative immunoturbidimetric
determination of the immunoglobulins A (IgA), G (IgG) and M (IgM) in
human serum.,Immunoglobulins direct IgG Reagent Kit-The
IMMUNOGLOBULINS direct IgA, IgG, IgM Multipurpose reagents
have been designed for the quantitative immunoturbidimetric
determination of the immunoglobulins A (IgA), G (IgG) and M (IgM) in
human serum.,Immunoglobulins direct IgA Reagent Kit-The
IMMUNOGLOBULINS direct IgA, IgG, IgM Multipurpose reagents
have been designed for the quantitative immunoturbidimetric

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of the immunoglobulins A (IgA), G (IgG) and M (IgM) in
human serum.,RF Standard-Standard for the determination of
Rheumatoid factors (RF),Anti-Streptolysin-O Standard-The ASO
Standard is used for calibration of the immunoturbidimetric anti-
STREPTOLYSIN-O assays.,CRP Standard-CRP multipurpose
reagents have been designed for the quantitative immunoturbidimetric
determination of C-reactive Protein (CRP) in human serum and
plasma.,CRP Reagent Kit-CRP multipurpose reagents have been
designed for the quantitative i mmunoturbidimetric determination of C-
reactive Protein (CRP) in human serum and plasma.,Cystatin-C
liquidirect-CYSTATIN-C liquidirect test has been designed for the
quantitative determination of Cystatin-C in human
serum.,Microalbumin Standard-The MICROALBUMIN Standard is
used for calibration of the immunoturbidimetric MICROALBUMIN
assays.,Microalbumin-The Microalbumin test has been designed for
the quantitative determination of albumin in human urine.,Transferrin-
The Transferrin test has been designed for the quantitative
determination of transferrin in human serum.,C3/C4/TRF Standard-
The C3/C4/TRF Standard is used for calibration of the
immunoturbidimetric complement C3/C4 and transferrin
assays.,Complement C3-The Complement C3 test has been designed
for the quantitative determination of Complement C3 in human
serum.,Lipoprotein-(a) Standard-The LIPOPROTEIN (a) STANDARD
is used for calibration of the immunoturbidimetric LIPOPROTEIN (a)
assays.,Lipoprotein-(a)-LIPOPROTEIN (a) test has been designed for
the quantitative determination of lipoprotein (a) (Lp(a)) in human
serum and plasma (EDTA).,Apolipoprotein-A1/B Standard-The APO
A1/B Standard is used for calibration of the immunoturbidimetric
APOLIPOPROTEIN A1 (APO A1) and APOLIPOPROTEIN B (APO B)
assays.,Apolipoprotein-B-APOLIPOPROTEIN B test has been
designed for the quantitative determination of Apolipoprotein B (APO
B) in human serum.,Apolipoprotein A1-APOLIPOPROTEIN B test has
been designed for the quantitative determination of Apolipoprotein B
(APO B) in human serum.,auto-Bilirubin-T liquicolor-auto-BILIRUBIN-
T liquicolor reagent has been designed for the quantitative

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of total bilirubin in human serum and heparinised
plasma particularly for automated working techniques.,auto-Bilirubin-D
liquicolor-auto-BILIRUBIN-D liquicolor reagent has been designed for
the quantitative determination of direct bilirubin in human serum and
heparinised plasma particularly for automated working
techniques,Bilirubin D+T liquicolor-BILIRUBIN D+T liquicolor test has
been designed for the quantitative determination of bilirubin in human
serum and heparinised plasma. It may be employed for manual
working techniques.,Uric Acid liquicolor Plus-URIC ACID liquicolorplus
test has been designed for the quantitative determination of uric acid
in human serum and plasma.,TIBC-TIBC multipurpose reagents have
been designed for sample preparation for the quantitative
determination of total iron binding capacity (TIBC) in human serum
and heparinised plasma.,Urea liquiUV-UREA liquiUV reagent has
been designed for the quantitative determination of urea in human
serum, plasma, except ammonium heparinate plasma, or urine.,Urea
liquicolor (R2)-UREA liquicolor has been designed for the quantitative
determination of urea in human serum and plasma (no heparinized
plasma).,Urea liquicolor (R1)-UREA liquicolor has been designed for
the quantitative determination of urea in human serum and plasma (no
heparinized plasma).,Urea liquicolor-UREA liquicolor has been
designed for the quantitative determination of urea in human serum
and plasma (no heparinized plasma).,Potassium Liquirapid-
POTASSIUM liquirapid has been designed for the quantitative
determination of ionised potassium in human serum and lithium-
heparin plasma.,Creatinine enzym Liquicolor-CREATININE (enzym)
liquicolor test has been designed for the quantitative determination of
creatinine in human serum and heparinised plasma.,auto-Creatinine
liquicolor-auto-CREATININE liquicolor test has been designed for the
quantitative determination of creatinine in human serum, heparinised
plasma and urine particularly for automated working
techniques.,Creatinine liquicolor-CREATININE liquicolor test has been
designed for the quantitative determination of creatinine in human
serum, heparinised plasma and urine.,Phosphorus Liquirapid-
PHOSPHORUS liquirapid test has been designed for the quantitative

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of inorganic phosphorus in human serum.,HDL
Cholesterol-HDL-CHOLESTEROL has been designed for the
quantitative determination of HDL-cholesterol in human serum, EDTA-
plasma and heparinised plasma.,Bilirubin liquicolor-BILIRUBIN
liquicolor DCA test has been designed for the quantitative
determination of bilirubin in human serum and plasma (heparinised
and EDTA-plasma).,ANA LIA XL(IMTEC)-IMTEC-ANA-LIA XL is an
IVD assay for the qualitative determination of 18 IgG class antibodies
against dsDNA, Nucleosome, Histones, SmD1, PCNA, ribosomal P0
(RPP), SS-A/Ro 60, SS-A/Ro 52, SS-B/La, CENP-B, Scl70, U1-
snRNP, AMA M2, Jo-1, PM-Scl, Mi-2, Ku and DFS70 in human serum
or plasma.,Arthritis LIA(IMTEC)-IMTEC-Arthritis-LIA is an IVD
intended for the qualitative detection of 10 different autoantibodies in
human serum and plasma as an aid in the diagnosis of rheumatoid
arthritis.

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

602 IMP/IVD/2019/000424 M/S. HEMOSTAT D-DIMER-The HUMAN HEMOSTAT D-DIMER is an CDSCO Class C
MEDSOURCE assay for quantitative determination of D-dimer in citrated plasma. It is
OZONE intended for professional use as an aid in diagnosis of
BIOMEDICALS thromboembolic events e.g. exclusion of DVT (deep vein thrombosis)
PVT LTD and PE (pulmonary embolism). It is suitable for semi-automated and
automated applications,HemoStat aPTT-EL-HEMOSTAT aPTT-EL has
been designed for the determination of the activated partial
thromboplastin time in human plasma (citrate plasma).,HemoStat
Fibrinogen-HEMOSTAT FIBRINOGEN has been designed for the
manual and automated determination of fibrinogen in human plasma
(citrate plasma).,HemoStat Control Plasma normal-HEMOSTAT
CONTROL PLASMA NORMAL and HEMOSTAT CONTROL PLASMA
ABNORMAL have been designed for quality control of the
HEMOSTAT tests THROMBOPLASTINliquid, THROMBOPLASTIN-SI,
aPTT-EL, FIBRINOGEN and THROMBIN TIME,HemoStat Control
Plasma abnormal-HEMOSTAT CONTROL PLASMA NORMAL and
HEMOSTAT CONTROL PLASMA ABNORMAL have been designed
for quality control of the HEMOSTAT tests THROMBOPLASTINliquid,
THROMBOPLASTIN-SI, aPTT-EL, FIBRINOGEN and THROMBIN
TIME.,HemoStat Thromboplastin-SI-HEMOSTAT
THROMBOPLASTINliquid and HEMOSTAT THROMBOPLASTIN-SI
have been designed for the manual and automated determination of
the prothrombin time (Quick, PT).

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

603 IMP/IVD/2019/000425 Tosoh India Pvt Alegria Anti-Annexin V IgM(Orgentec)-For the quantitative CDSCO Class B
Ltd measurement of IgM class autoantibodies against annexin V in human
serum or plasma samples,Extractable Nuclear Antigens (ENA) combi
(Orgentec)-For the quantitative determination of IgG antibodies
against extractable nuclear antigens (ENA): SS-A (52 and 60 kDa),
SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma
samples,Anti-Cardiolipin IgG/IgM (Orgentec)-For the quantitative
measurement of IgG and IgM class autoantibodies against cardiolipin
in human serum or plasma,Anti-Cardiolipin IgA (Orgentec)-for the
quantitative measurement of IgA class autoantibodies against
cardiolipin in human serum or plasma samples,Anti-Cardiolipin Screen
(Orgentec)-For the quantitative measurement of IgG, IgM and IgA
class autoantibodies against cardiolipin in human serum or plasma
samples,Anti-beta-2-Glycoprotein I Screen (Orgentec)-For the
quantitative measurement of I IgG, IgM and IgA class autoantibodies
against beta-2-Glycoprotein I in human serum or plasma.,Rheumatoid
Factor IgA (Orgentec)-For the quantitative measurement of IgA class
rheumatoid factor in human serum or plasma samples,Rheumatoid
Factor IgG (Orgentec)-For the quantitative measurement of IgG class
rheumatoid factor in human serum or plasma samples,Rheumatoid
Factor IgM (Orgentec)-For the quantitative measurement of IgM class
rheumatoid factor in human serum or plasma samples,Anti-
Deamidated Gliadin Protein (DGP) Screen (Orgentec)-For the
quantitative measurement of IgG and IgA class antibodies against
deamidated gliadin protein epitopes (DGP) in human serum or
plasma,Anti-Double Stranded DNA (dsDNA) IgG(Orgentec)-For the
quantitative measurement of IgG class autoantibodies against double-
stranded DNA in human serum or plasma,25-OH Vitamin D3/D2
(Orgentec)-For the quantitative measurement of total concentration of
25-(OH)-Vitamin D2 and 25-(OH)-Vitamin D3 in human serum or
plasma samples (EDTA plasma, heparin plasma, citrate
plasma),Calprotectin (Orgentec)-For the quantitative measurement of
calprotectin in human stool samples to be used in the assessment of
intestinal inflammatory disorders,Anti-Proteinase 3 high sensitive
(PR3 hs) (Orgentec)-For the quantitative measurement of IgG class
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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
autoantibodies against proteinase 3 (PR3) in human serum or
plasma,Anti Nuclear Antibodies (ANA) Detect (Orgentec)-For the
qualitative measurement of IgG class autoantibodies against SS-A-52
(Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A,
RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA,
ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone
complex, histone H1, histone H2A, histone H2B, histone 3, histone
H4, Pm-Scl-100 and centromere B in human serum or plasma
samples,Anti-Cyclic Citrullinated Peptides high sensitive (CCP hs)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against cyclic citrullinated peptides (CCP) in human
serum or plasma,Anti-Double Stranded DNA (dsDNA) IgA (Orgentec)-
For the quantitative measurement of IgA class autoantibodies against
double stranded DNA in human serum or plasma,Anti-Double
Stranded DNA (dsDNA) IgM (Orgentec)-For the quantitative
measurement of IgM class autoantibodies against double stranded
DNA in human serum or plasma,Anti-Double Stranded DNA (dsDNA)
Screen (Orgentec)-For the quantitative measurement of IgG, IgM and
IgA class autoantibodies against double-stranded DNA in human
serum or plasma,Anti-Single Stranded DNA (ssDNA) (Orgentec)-For
the quantitative measurement of IgG class autoantibodies against
single-stranded DNA in human serum or plasma,Anti-RNP-70
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against RNP 70 in human serum or plasma,Anti-
Centromere B (Orgentec)-For the quantitative measurement of IgG
class autoantibodies against centromere B in human serum or
plasma,Anti-alpha-Fodrin IgG/IgA (Orgentec)-For the for the
quantitative measurement of IgG and IgA class autoantibodies against
alpha-Fodrin in human serum or plasma,Anti-Annexin V IgG/IgM
(Orgentec)-For the quantitative measurement of IgG and IgM class
autoantibodies against Annexin V in human serum or plasma,Anti-
Intrinsic Factor (Orgentec)-For the quantitative measurement of IgG
class autoantibodies against intrinsic factor in human serum or
plasma,Anti-Sjogren Antigen 52 (SS-A 52) (Orgentec)-For the
quantitative measurement of IgG class autoantibodies to SS-A 52 in

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
human serum or plasma,Anti-Sjogren Antigen 60 (SS-A 60)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies to SS-A 60 in human serum or plasma,Anti-Neutrophil
Cytoplasmic Antibodies Screen high sensitive (ANCAscreen hs)
(Orgentec)-For the qualitative measurement of IgG class
autoantibodies against PR3 and MPO in human serum or
plasma,Alegria Anti Nuclear Antibodies (ANA Detect)(Orgentec)-For
the qualitative measurement of IgG class autoantibodies against SS-
A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-
A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA,
ssDNA, polynucleosomes, mononucleosomes, histone complex,
histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-
100 and centromere B in human serum or plasma samples.,Alegria
Anti-Thyroglobulin (TG)(Orgentec)-For the quantitative measurement
of IgG class autoantibodies against thyroglobulin (TG) in human
serum or plasma samples,Alegria Anti-Thyroid Peroxidase (TPO)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against Thyroid Peroxidase (TPO) in human serum or
plasma samples,Alegria Anti-double stranded DNA (dsDNA)
IgA(Orgentec)-For the quantitative measurement of IgA class
autoantibodies against double-stranded DNA (dsDNA) in human
serum or plasma samples,Alegria Anti-double stranded DNA (dsDNA)
IgG (Orgentec)-For the quantitative measurement of IgG class
autoantibodies against double-stranded DNA (dsDNA) in human
serum or plasma samples,Alegria Anti-double stranded DNA (dsDNA)
IgM (Orgentec)-For the quantitative measurement of IgM class
autoantibodies against double-stranded DNA (dsDNA) in human
serum or plasma,Alegria Anti-double stranded DNA (dsDNA) Screen
(Orgentec)-For the quantitative measurement of IgG, IgM, IgA class
autoantibodies against double-stranded (dsDNA) in human serum or
plasma samples,Alegria Anti-single stranded DNA (ssDNA)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against single-stranded DNA (ssDNA) in human serum
or plasma samples,Alegria Extractable Nuclear Antigens (ENA)
Screen (Orgentec)-For the qualitative screening of IgG class

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
autoantibodies against extractable nuclear antigens (ENA): SS-A 60,
SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or
plasma samples,Alegria Anti-Histone(Orgentec)-For the quantitative
measurement of IgG class autoantibodies against histone in human
serum or plasma samples,Alegria Anti-Sjogren Antigen (SS-A)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against SS-A 60 and SS-A 52 in human serum or
plasma samples.,Alegria Anti-Sjogren Antigen (SS-B) (Orgentec)-For
the quantitative measurement of IgG class autoantibodies against SS-
B in human serum or plasma samples,Alegria Anti-Smit Antigen (Sm)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against Sm in human serum or plasma
samples,Alegria Anti-Ribonucleoproteins/Smith Antigen (RNP/Sm)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against RNP/Sm in human serum or plasma
samples,Alegria Anti-Scl-70 (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against Scl-70 in human
serum or plasma samples,Alegria Anti-Jo-1(Orgentec)-For the
quantitative measurement of IgG class autoantibodies against Jo-1 in
human serum or plasma samples,Alegria Anti-Cardiolipin IgA
(Orgentec)-For the quantitative measurement of IgA class
autoantibodies against cardiolipin in human serum or plasma
samples,Alegria Anti-Cardiolipin IgG (Orgentec)-For the quantitative
measurement of IgG class antibodies against cardiolipin in human
serum or plasma samples,Alegria Anti-Cardiolipin IgM (Orgentec)-For
the quantitative measurement of IgM class autoantibodies against
cardiolipin in human serum or plasma samples,Alegria Anti-Cardiolipin
Screen (Orgentec)-for the quantitative measurement of IgG, IgA and
IgM class autoantibodies against cardiolipin in human serum or
plasma samples,Alegria Anti Mitochondrial Antibodies - M2 (AMA-M2)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against mitochondrial M2 subtype antigen in human
serum or plasma samples,Alegria Anti-Ribosomal P Proteins (Rib-P)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against ribosomal P proteins in human serum or

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
plasma samples,Alegria Anti-Proteinase 3 (PR3) (cANCA)(Orgentec)-
For the quantitative measurement of IgG class autoantibodies against
proteinase 3 (PR3) in human serum or plasma samples,Alegria Anti-
Myeloperoxidase (MPO) (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against myeloperoxidase (MPO) in human
serum or plasma samples,Alegria Anti-Insulin (Orgentec)-For the
quantitative measurement of IgG class antibodies against insulin in
human serum or plasma samples,Alegria Anti-beta-2-Glycoprotein I
IgA (Orgentec)-For the quantitative measurement of IgA class
autoantibodies against beta-2-Glycoprotein I in human serum or
plasma samples,Alegria Anti-alpha-Fodrin IgG (Orgentec)-For the
quantitative measurement of IgG class autoantibodies against alpha-
Fodrin in human serum or plasma samples,Alegria Anti-Annexin V IgG
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against annexin V in human serum or plasma
samples,Alegria Anti-Saccharomyces Cerevisiae Autoantibodies
(ASCA) IgA (Orgentec)-For the quantitative measurement of IgA class
anti-Saccharomyces cerevisiae autoantibodies (ASCA) in human
serum or plasma samples,Alegria Anti-beta-2-Glycoprotein I IgG
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against beta-2-Glycoprotein I in human serum or
plasma samples,Alegria Anti-beta-2-Glycoprotein I IgM (Orgentec)-For
the quantitative measurement of IgM class autoantibodies against
beta-2-Glycoprotein I in human serum or plasma samples,Alegria Anti-
beta-2-Glycoprotein I Screen (Orgentec)-For the quantitative
measurement of IgG, IgA and IgM class autoantibodies against beta-
2-Glycoprotein I in human serum or plasma samples,Alegria
Rheumatoid Factor IgA (Orgentec)-For the quantitative measurement
of IgA class rheumatoid factor (RF) in human serum or plasma
samples,Alegria Rheumatoid Factor IgG (Orgentec)-For the
quantitative measurement of IgG class rheumatoid factor (RF) in
human serum or plasma samples,Alegria Rheumatoid Factor IgM
(Orgentec)-For the quantitative measurement of IgM class rheumatoid
factor (RF) in human serum or plasma samples,Alegria Rheumatoid
Factor Screen (Orgentec)-For the quantitative measurement of IgG,

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
IgA and IgM class rheumatoid factor (RF) in human serum or plasma
samples,Alegria Anti-Bactericidal Permeability Increasing Protein
(BPI) (Orgentec)-For the quantitative measurement of IgG class
autoantibodies against bactericidal permeability-increasing protein
(BPI) in human serum or plasma samples,Alegria Anti-Elastase
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against Elastase in human serum or plasma
samples,Alegria Anti-Cathepsin G (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against Cathepsin G in
human serum or plasma samples,Alegria Anti-Lysozyme (Orgentec)-
For the quantitative measurement of IgG class autoantibodies against
Lysozyme in human serum or plasma samples,Alegria Anti-Lactoferrin
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against Lactoferrin in human serum or plasma
samples,Alegria Anti-Nucleosome (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against Nucleosomes in
human serum or plasma samples,Alegria Anti-Phospholipid Screen
IgG (Orgentec)-For the quantitative measurement of IgG class
autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl
inositol, phosphatidic acid and beta-2-glycoprotein I in human serum
or plasma samples,Alegria Anti-Phospholipid Screen IgM (Orgentec)-
For the quantitative measurement of IgM class autoantibodies against
cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic
acid and beta-2-glycoprotein I in human serum or plasma
samples,Alegria Anti-Parietal Cell (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against the alpha and beta-
subunits of the parietal cell H+/K+-ATPase in human serum or plasma
samples,Alegria Anti-RNP-70 (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against RNP-70 in human
serum or plasma samples,Alegria Anti-Centromere B (Orgentec)-For
the quantitative measurement of IgG class autoantibodies against
centromere B in human serum or plasma samples,Alegria Anti-Gliadin
IgA (Orgentec)-For the quantitative measurement of IgA class
autoantibodies against gliadin in human serum or plasma
samples,Alegria Anti-Gliadin IgG(Orgentec)-For the quantitative

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
measurement of IgG class autoantibodies against gliadin in human
serum or plasma samples,Alegria Anti-Gliadin Screen (Orgentec)-For
the quantitative measurement of IgG and IgA class autoantibodies
against gliadin in human serum or plasma samples,Alegria Anti-
Phosphatidyl Serine IgG (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against phosphatidyl serine in human
serum or plasma samples,Alegria Anti-Phosphatidyl Serine IgM
(Orgentec)-For the quantitative measurement of IgM class
autoantibodies against phosphatidyl serine in human serum or plasma
samples,Alegria Anti-Phosphatidyl Inositol IgG (Orgentec)-For the
quantitative measurement of IgG class autoantibodies against
phosphatidyl inositol in human serum or plasma samples,Alegria Anti-
Phosphatidyl Inositol IgM (Orgentec)-For the quantitative
measurement of IgM class autoantibodies against phosphatidyl
inositol in human serum or plasma samples,Alegria Anti-Phosphatidic
Acid IgG (Orgentec)-For the quantitative measurement of IgG class
autoantibodies against phosphatidic acid in human serum or plasma
samples,Alegria Anti-Phosphatidic Acid IgM (Orgentec)-For the
quantitative measurement of IgM class autoantibodies against
phosphatidic acid in human serum or plasma samples,Alegria Anti
Nuclear Antibodies (ANA) Screen (Orgentec)-For the qualitative
measurement of IgG class autoantibodies against SS-A 60, SS-A 52,
SS-B, RNP-70, Sm, RNP/Sm, Scl-70, centromere B, Jo-1 in human
serum or plasma samples,Alegria Anti-Tissue-Transglutaminase IgA
(Orgentec)-For the quantitative measurement of IgA class
autoantibodies against tissue transglutaminase (tTG) in human serum
or plasma samples,Alegria Anti-Tissue-Transglutaminase IgG
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against tissue transglutaminase (tTG) in human serum
or plasma samples,Alegria Anti-Tissue-Transglutaminase Screen
(Orgentec)-For the quantitative measurement of IgG and IgA class
autoantibodies against tissue transglutaminase (tTG) in human serum
or plasma samples,Alegria Anti-Prothrombin IgA(Orgentec)-For the
quantitative measurement of IgA class autoantibodies against
prothrombin in human serum or plasma samples,Alegria Anti-

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Prothrombin IgG (Orgentec)-For the quantitative measurement of IgG
class autoantibodies against prothrombin in human serum or plasma
samples,Alegria Anti-Prothrombin IgM (Orgentec)-For the quantitative
measurement of IgM class autoantibodies against prothrombin in
human serum or plasma samples,Alegria Anti-Prothrombin Screen
(Orgentec)-For the quantitative measurement of IgG, IgA and IgM
class autoantibodies against prothrombin in human serum or plasma
samples,Alegria Anti-alpha-Fodrin IgA (Orgentec)-For the quantitative
measurement of IgA class autoantibodies against alpha-Fodrin in
human serum or plasma samples,Alegria Anti-Saccharomyces
Cerevisiae Autoantibodies (ASCA) IgG (Orgentec)-For the quantitative
measurement of IgG class anti-Saccharomyces cerevisiae
autoantibodies (ASCA) in human serum or plasma samples,Alegria
Anti-Intrinsic Factor (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against intrinsic factor in human serum or
plasma samples,Alegria Anti-Mutated Citrullinated Vimentin (MCV)
(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against mutated citrullinated vimentin (MCV) in human
serum or plasma samples,Alegria Anti-C1q (Orgentec)-For the
quantitative measurement of IgG class autoantibodies against C1q in
human serum or plasma samples,Alegria Anti-Glomerular Basement
Membrane (GBM) (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against glomerular basement membrane
(GBM) in human serum or plasma samples,Alegria Anti-Deamidated
Gliadin Protein Epitopes (DGP) IgA(Orgentec)-For the quantitative
measurement of IgA class antibodies against deamidated gliadin
protein epitopes (DGP) in human serum or plasma samples,Alegria
Anti-Deamidated Gliadin Protein Epitopes (DGP) IgG(Orgentec)-For
the quantitative measurement of IgG class antibodies against
deamidated gliadin protein epitopes (DGP) in human serum or plasma
samples,Alegria Anti-Deamidated Gliadin Protein Epitopes (DGP)
Screen (Orgentec)-For the quantitative measurement of IgA and IgG
class antibodies against deamidated gliadin protein epitopes (DGP) in
human serum or plasma samples,Alegria Anti-Sjogren Antigen 52
(SS-A 52) (Orgentec)-For the quantitative measurement of IgG class

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
autoantibodies against SS-A 52 in human serum or plasma
samples,Alegria Anti-Liver-kidney Microsomes (LKM-1) (Orgentec)-
For the quantitative measurement of IgG class antibodies against type
1 liver-kidney microsomes (LKM-1) in human serum or plasma
samples,Alegria Anti-Sp100 (Orgentec)-For the quantitative
measurement of IgG class antibodies against the nuclear body protein
Sp100 in human serum or plasma samples,Alegria Anti-Glycoprotein
210 (Gp210) (Orgentec)-For the quantitative measurement of IgG
class antibodies against the nuclear core glycoprotein 210 (Gp210) in
human serum or plasma samples,Alegria Anti-Soluble Liver Antigen
(SLA) (Orgentec)-For the quantitative measurement of IgG class
antibodies against soluble liver antigen (SLA) in human serum or
plasma samples.,Alegria Anti-LC1(Orgentec)-For the quantitative
measurement of IgG class antibodies against the liver cytosolic
protein type 1 (LC1) in human serum or plasma samples,Alegria Anti-
Sjogren Antigen 60 (SS-A 60) (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against SS-A 60 in human
serum or plasma samples,Alegria 25-OH Vitamin D3/D2(Orgentec)-
For the quantitative measurement of the total concentration of 25-
(OH)-Vitamin D2 and 25-(OH)-Vitamin D3 in human serum or plasma
samples (EDTA plasma, heparin plasma, citrate plasma),Alegria 25-
OH Vitamin D3/D2 Control Set(Orgentec)-25-OH Vitamin D3/D2
Control Set contains external control materials with defined
concentrations of 25-OH Vitamin D3/D2 for the quantitative Alegria 25-
OH Vitamin D3/D2 assay,Alegria Calprotectin (Orgentec)-For the
quantitative measurement of calprotectin in human stool samples to
be used in the assessment of intestinal inflammatory disorders,Alegria
Lactoferrin (Orgentec)-For the quantitative measurement of lactoferrin
in human stool samples to be used in the assessment of intestinal
inflammatory disorders,Alegria Alpha-1-Antitrypsin(Orgentec)-For the
quantitative measurement of Alpha-1 Antitrypsin in human stool
samples,Alegria Anti-Cyclic Citrullinated Peptides high sensitive (CCP
hs)(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against cyclic citrullinated peptides (CCP) in human
serum or plasma samples,Alegria Positive Control(Orgentec)-Alegria

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Positive Control is an ELISA based Alegria Test Strip intended for
quality control of the Alegria system and Alegria reagents,Alegria
Negative Control(Orgentec)-Alegria Negative Control is an ELISA
based Alegria Test Strip intended for quality control of the Alegria
system and Alegria reagents,Alegria Anti-Proteinase 3 High Sensitive
(PR3 hs)(Orgentec)-For the quantitative measurement of IgG class
autoantibodies against proteinase 3 (PR3) in human serum or plasma
samples,Alegria Anti-Neutrophil Cytoplasmic Antibodies high sensitive
(ANCAscreen hs) (Alegria)-For the qualitative screening of IgG class
autoantibodies against PR3 and MPO in human serum or plasma
samples,Anti Mitochondrial Antibodies - M2 (AMA-M2) (Orgentec)-For
the quantitative measurement of IgG class autoantibodies against
mitochondrial M2 subtype antigen in human serum or plasma
samples,Anti-Ribosomal P Proteins (Rib-P) (Orgentec)-For the
quantitative measurement of IgG class autoantibodies against
ribosomal P proteins in human serum or plasma samples,Anti-
Proteinase 3 (PR3) (cANCA) (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against proteinase 3 (PR3)
in human serum or plasma samples,Anti-Myeloperoxidase (MPO)
(pANCA) (Orgentec)-For the quantitative measurement of IgG class
autoantibodies against myeloperoxidase (MPO) in human serum or
plasma,Anti-Insulin (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against insulin in human serum or
plasma,Anti-beta-2-Glycoprotein I IgG/IgM (Orgentec)-For the
quantitative measurement of I IgG and IgM class autoantibodies
against beta-2-Glycoprotein I in human serum or plasma,Anti-beta-2-
Glycoprotein I IgA (Orgentec)-For the quantitative measurement of I
IgA class autoantibodies against beta-2-Glycoprotein I in human
serum or plasma,Rheumatoid Factor Screen (Orgentec)-For the
quantitative measurement of IgG, IgM and IgA class rheumatoid factor
in human serum or plasma samples,Anti-Bactericidal Permeability
Increasing Protein (BPI) (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against bactericidal permeability
increasing protein, BPI, in human serum or plasma,Anti-
Elastase(Orgentec)-For the quantitative measurement of IgG class

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
autoantibodies against Elastase in human serum or plasma,Anti-
Cathepsin G (Orgentec)-For the quantitative measurement of IgG
class autoantibodies against Cathepsin G in human serum or
plasma,Anti-Lactoferrin (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against Lactoferrin in human serum or
plasma,Anti-Nucleosome (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against nucleosomes in
human serum or plasma,Anti-Phospholipid Screen IgG/IgM
(Orgentec)-For screening the presence of IgG and IgM class
autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl
inositol, phosphatidic acid and beta-2-glycoprotein I in human serum
or plasma,Anti-Neutrophil Cytoplasmic Antibodies (ANCA) combi
(Orgentec)-For the qualitative measurement of anti-neutrophil
cytoplasmic antibodies (ANCA) directed against PR3, MPO, BPI,
Elastase, Cathepsin G, Lysozyme and Lactoferrin in human serum or
plasma,Anti-Parietal Cell (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against the alpha- and
beta-subunits of the parietal cell H+/K+-ATPase in human serum or
plasma,Anti-Gliadin IgA(Orgentec)-For the quantitative measurement
of IgA class autoantibodies against gliadin in human serum or
plasma,Anti-Gliadin IgG (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against gliadin in human serum or
plasma.,Anti-Gliadin Screen (Orgentec)-For the simultaneous
quantitative measurement of IgG and IgA class autoantibodies against
gliadin in human serum or plasma,Anti-Phosphatidyl Serine IgG/IgM
(Orgentec)-For the quantitative measurement of IgG and IgM class
autoantibodies against phosphatidyl serine in human serum or
plasma,Anti-Phosphatidyl Inositol IgG/IgM (Orgentec)-For the
quantitative measurement of IgG and IgM class autoantibodies
against phosphatidyl inositol in human serum or plasma,Anti-
Phosphatidic Acid IgG/IgM(Orgentec)-For the quantitative
measurement of IgG and IgM class autoantibodies against
phosphatidic acid in human serum or plasma,Anti Nuclear Antibodies
(ANA) Screen (Orgentec)-for the qualitative measurement of IgG class
autoantibodies against SS-A 60, SSA 52, SS-B, RNP-70, Sm,

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
RNP/Sm, Scl-70, centromere B, Jo-1 in human serum or plasma
samples,Anti Nuclear Antibodies (ANA) Combi (Orgentec)-For the
qualitative measurement of ANA autoantibodies directed against RNP-
70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, centromere B
and Jo-1 in human serum or plasma,Anti-Tissue-Transglutaminase
IgA (Orgentec)-For the quantitative measurement of IgA class
autoantibodies to tissue transglutaminase (tTG) in human serum or
plasma,Anti-Tissue-Transglutaminase IgG(Orgentec)-For the
quantitative measurement of IgG class autoantibodies to tissue-
transglutaminase (tTG) in human serum or plasma,Anti-Tissue-
Transglutaminase Screen (Orgentec)-For the quantitative
measurement of IgG and IgA class autoantibodies to tissue
transglutaminase (tTG) in human serum or plasma,Anti-Prothrombin
IgG/IgM (Orgentec)-For the quantitative measurement of IgG and IgM
class autoantibodies against prothrombin in human serum or
plasma,Anti-Prothrombin IgA (Orgentec)-For the quantitative
measurement of IgA class autoantibodies against prothrombin in
human serum or plasma,Anti-Prothrombin Screen (Orgentec)-For the
quantitative measurement of IgG, IgM and IgA class autoantibodies
against prothrombin in human serum or plasma,Extractable Nuclear
Antigen-4-Profile (ENA-4-Profile)(Orgentec)-For the qualitative
measurement of IgG class autoantibodies directed against the
extractable nuclear antigens SS-A (52 and 60 kDa, Ro), SS-B (La),
Sm and RNP/Sm in human serum or plasma,Anti-Saccharomyces
Cerevisiae Autoantibodies (ASCA) IgG/IgA (Orgentec)-For the
quantitative measurement of IgG and IgA class anti-Saccharomyces
cerevisiae antibodies (ASCA) in human serum or plasma,Extractable
Nuclear Antigen-6-Profile (ENA-6-Profile) (Orgentec)-For the
qualitative measurement of IgG class autoantibodies directed against
the extractable nuclear antigens SS-A (52 and 60 kDa, Ro), SS-B
(La), Sm, RNP/Sm, Scl-70, and Jo-1 in human serum or plasma,Anti-
Mutated Citrullinated Vimentin (MCV) (Orgentec)-For the quantitative
measurement of IgG class autoantibodies against mutated
citrullinated vimentin (MCV) in human serum or plasma,Anti-C1q
(Orgentec)-For the quantitative measurement of IgG class

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
autoantibodies against C1q in human serum or plasma,Anti-
Glomerular Basement Membrane (GBM) (Orgentec)-For the
quantitative measurement of IgG class autoantibodies to glomerular
basement membrane (GBM) in human serum or plasma,Anti-
Deamidated Gliadin Protein (DGP) IgA (Orgentec)-For the quantitative
detection of antibodies (IgA) against deamidated gliadin protein
epitopes (DGP) in human serum or plasma,Anti-Deamidated Gliadin
Protein (DGP) IgG (Orgentec)-For the quantitative detection of
antibodies (IgG) against deamidated gliadin protein epitopes (DGP) in
human serum or plasma,Anti-Thyroglobulin (TG) (Orgentec)-For the
quantitative measurement of IgG class autoantibodies against
thyroglobulin (TG) in human serum or plasma samples,Anti-Thyroid
peroxidase (TPO) (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against thyroid peroxidase (TPO) in human
serum or plasma.,Extractable Nuclear Antigen (ENA) Screen
(Orgentec)-For the qualitative screening of IgG class autoantibodies
against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B,
Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma
samples,Anti-Histone (Orgentec)-For the quantitative measurement of
IgG class autoantibodies to histone in human serum or plasma,Anti-
Sjogren Antigen (SS-A) (Orgentec)-For the quantitative measurement
of IgG class autoantibodies against SS-A (52 and 60 kDa) in human
serum or plasma samples,Anti-Sjogren Antigen (SS-B) (Orgentec)-For
the quantitative measurement of IgG class autoantibodies against SS-
B (La) in human serum or plasma,Anti-Smit Antigen (Sm) (Orgentec)-
For the quantitative measurement of IgG class autoantibodies against
Sm in human serum or plasma samples,Anti-Ribonucleoprotein/Smith
Antigen (RNP/Sm) (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against RNP/Sm in human serum or plasma
samples,Anti-Scl-70 (Orgentec)-For the quantitative measurement of
IgG class autoantibodies against Scl-70 in human serum or
plasma,Anti-Jo-1 (Orgentec)-For the quantitative measurement of IgG
class autoantibodies against Jo-1 in human serum or plasma
samples,Nucleo-9-Line Immunoblot(Orgentec)-Nucleo-9-Line
Immunoblot assay is a membrane based enzyme immunoassay for

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
the semi-quantitative measurement of IgG class autoantibodies to
dsDNA, nucleosomes, SS-A (52 a 60 kDa), SS-B, Sm, RNP/Sm, Scl-
70, Jo-1 and centromere B in human serum or plasma.,Ferritin
ELISA(Orgentec)-Ferritin is an ELISA test system for the quantitative
measurement of ferritin in human serum or plasma.,Micro-Albumin
ELISA(Orgentec)-Micro-Albumin is a competitive ELISA test system
for the quantitative measurement of human albumin in
urine.,Thyroglobulin ELISA(Orgentec)-Thyroglobulin is an ELISA test
system for the quantitative measurement of thyroglobulin in human
serum or plasma.,Liver-9-Line 2nd Generation Immunoblot(Orgentec)-
Liver-9-Line 2nd Generation Immunoblot assay is a membrane based
enzyme immunoassay for the semiquantitative measurement of IgG
class autoantibodies to AMA-M2, Sp100, gp210, SLA/LP, LKM-1, LC1,
F-actin, actinin and tropomyosin in human serum or plasma.,Myositis
plus Immunoblot(Orgentec)-Myositis plus Immunoblot assay is a
membrane based enzyme immunoassay for the semi-quantitative
measurement of IgG class autoantibodies to AMA-M2, Jo-1, PM-ScI-
100, PL-7, PL-12, Mi-2, Ku (p70/80), Rib-P and SRP in human serum
or plasma.,ANCA-3-Line Immunoblot(Orgentec)-ANCA-3-Line
Immunoblot assay is a membrane based enzyme immunoassay for
the semi-quantitative measurement of IgG class autoantibodies to
PR3, MPO and GBM in human serum or plasma.,ANA-9-Line
Immunoblot(Orgentec)-ANA-9-Line Immunoblot assay is a membrane
based enzyme immunoassay for the semi-quantitative measurement
of IgG class autoantibodies to extractable nuclear antigens SS-A 52,
SS-A 60, SS B, RNP/Sm, Sm, centromere B, Jo-1, Scl-70 and
ribosomal P proteins in human serum or plasma.,Gastro-5-Line
Immunoblot(Orgentec)-Gastro-5-Line Immunoblot assay is a
membrane based enzyme immunoassay for the semi-quantitative
measurement of IgG and IgA class autoantibodies to intrinsic factor,
parietal cell H+/K+ ATPase, tissue transglutaminase, Mannan from
Saccharomyces cerevisiae and gliadin in human serum or plasma.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

604 IMP/IVD/2019/000426 Beckman Coulter Alpha-1-AcidGlycoprotein(Alpha-1-AcidGlycoprotein)-Immuno- CDSCO Class B

India Private turbidimetric test for the quantitative determination of α-1
Limited Hisaria acidglycoprotein in human serum and plasma on Beckman Coulter
Warehouse analysers,Haptoglobin(Haptoglobin)-Immuno-turbidimetric test for the
Ground Floor quantitative determination of haptoglobin in human serum and plasma
on Beckman Coulter analysers.

605 IMP/IVD/2019/000427 M/S Agappe Lyse reagent for 5 part differential hematology Analyzer(Lyse 5D)-to CDSCO Class B
Diagnostics Ltd be used for blood cell counting sizing and WBC differentiation
hemoglobin determination on mispa count plus hematology Analyzer.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

606 IMP/IVD/2019/000428 BioSystems OXALATE CONTROL URINE(OXALATE CONTROL URINE)-Control CDSCO Class B
Diagnostics Pvt. to verify the performance of the measurement procedure.,Alkaline
Ltd. washing solution(Alkaline washing solution)-Washing solution to clean
the internal parts of the instruments.,FRUCTOSAMINE CONTROL
SERUM(FRUCTOSAMINE CONTROL SERUM)-Control to verify the
performance of the measurement procedure.,GLUCOSE / UREA /
CREATININE STANDARD(GLUCOSE / UREA / CREATININE
STANDARD)-used to Standardize the Glucose/Urea/Creatinine kit.
,UNSATURATED IRON BINDING CAPACITY(UNSATURATED IRON
BINDING CAPACITY)-Reagents for measurement of UIBC
concentration in serum or heparinized plasma.,TRIGLYCERIDES
STANDARD(TRIGLYCERIDES STANDARD)-used to Standardize the
Cholesterol kit.,ALBUMIN STANDARD(ALBUMIN STANDARD)-used
to Standardize the albumin kit.,HEMOGLOBIN A1C CONTROL
(NORMAL)(HEMOGLOBIN A1C CONTROL (NORMAL))-The
Hemoglobin A1C Control is intended for quality control purposes only
and is supplied with suggested intervals of acceptable
values.,CHOLESTEROL STANDARD(CHOLESTEROL STANDARD)-
used to Standardize the Cholesterol kit.,URIC ACID
STANDARD(URIC ACID STANDARD)-used to Standardize the Uric
acid kit.,CALCIUM / MAGNESIUM STANDARD(CALCIUM /
MAGNESIUM STANDARD)-used to Standardize the
Calcium/Magnesium kit. ,PROTEIN (TOTAL) STANDARD(PROTEIN
(TOTAL) STANDARD)-Used to Standardize the albumin
kit.,OXALATE(OXALATE)-Reagents for measurement of oxalate
concentration in urine.,BETA-HYROXYBUTYRATE(BETA-
HYROXYBUTYRATE)-Reagents for measurement of beta-
hydroxybutyrate concentration in serum or plasma.,ENA – 6
Profile(ENA – 6 Profile)-Reagents for measurement of a ENA
Antibodies concentration in serum,Cholesterol LDL Direct(Cholesterol
LDL Direct)-Reagents for measurement of Cholesterol LDL Direct
concentration in serum,Cholesterol(Cholesterol)-Reagents for
measurement of Cholesterol concentration in serum,Calcium-
MTB(Calcium-MTB)-Reagents for measurement of calcium MTB
concentration in serum,Calcium Cresolphthalein(Calcium
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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Cresolphthalein)-Reagents for measurement of calcium
cresolphthalein concentration in serum,Calcium Arsenazo(Calcium
Arsenazo)-Reagents for measurement of calcium arsenazo
concentration in serum,Bilirubin (Total and Direct)(Bilirubin (Total and
Direct))-Reagents for measurement of bilirubin total and direct
concentration in serum,Bilirubin (Total)(Bilirubin (Total))-Reagents for
measurement of Bilirubin total concentration in serum,Bilirubin (Direct)
(Bilirubin (Direct))-Reagents for measurement of Bilirubin direct
concentration in serum,Asparate Aminotransferase (AST/GOT)
(Asparate Aminotransferase (AST/GOT))-Reagents for measurement
of AST/GOT concentration in serum,Albumin(Albumin)-Reagents for
measurement of albumin concentration in serum,Alanine
Aminotransferase (ALT/GPT)(Alanine Aminotransferase (ALT/GPT))-
Reagents for measurement of ALT/GPT concentration in
serum,Adenosine Deaminase (ADA)(Adenosine Deaminase (ADA))-
Reagents for measurement of adenosine deaminase concentration in
serum.,Acid Phosphatase (ACP)(Acid Phosphatase (ACP))-Reagents
for measurement of acid phosphatase concentration in serum,a-
amylase pancreatic(a-amylase pancreatic)-Reagents for
measurement of a amylase pancreatic concentration in serum.,a-
amylase EPS(a-amylase EPS)-Reagents for measurement of a
amylase EPS concentration in serum.,a-amylase Direct(a-amylase
Direct)-Reagents for measurement of a amylase direct concentration
in serum.,a- 1- Acid Glycoprotein(a- 1- Acid Glycoprotein)-Reagents
for measurement of a 1-acid glycoprotein concentration in
serum.,BIOCHEMISTRY CONTROL URINE II(BIOCHEMISTRY
CONTROL URINE II)-Control to verify the performance of the
measurement procedure of complete biochemical
parameters,Ethanol(Ethanol)-Reagents for measurement of Ethanol
concentration in serum,Ammonia(Ammonia)-Reagents for
measurement of Ammonia concentration in serum,Acid washing
solution(Acid washing solution)-Solution to verify the performance of
the measurement procedure,Concentrated washing
solution(Concentrated washing solution)-Washing solution being used
to clean the internal part of the instrument,Concentrated System

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
liquid(Concentrated System liquid)-Solution being used to clean the
internal part of the instrument,Rheumatoid Factors (RF) –
Slide(Rheumatoid Factors (RF) – Slide)-Reagents for measurement of
RF concentration in serum,Anti-Citrullinated Protein Antibodies
(ACPA)(Anti-Citrullinated Protein Antibodies (ACPA))-Reagents for
measurement of Citrullinated protein concentration in serum,Anti-
dsDNA Antibodies(Anti-dsDNA Antibodies)-Reagents for
measurement of dsDNA concentration in serum,Anti-Nucleasome
Antibodies (NCL)(Anti-Nucleasome Antibodies (NCL))-Reagents for
measurement of Nucleosome concentration in serum,Anti-Histones
Antibodies (HIST)(Anti-Histones Antibodies (HIST))-Reagents for
measurement of Histones concentration in serum,Anti-Ribosomal P
Antibodies (Rib P)(Anti-Ribosomal P Antibodies (Rib P))-Reagents for
measurement of Ribosomal P protein concentration in serum,Anti-
Sc170 Antibodies(Anti-Sc170 Antibodies)-Reagents for measurement
of Scl70 concentration in serum,Anti-Jo1 Antibodies(Anti-Jo1
Antibodies)-Reagents for measurement of anti Jo1 concentration in
serum,Anti-Centromere B Antibodies (CENP-B)(Anti-Centromere B
Antibodies (CENP-B))-Reagents for measurement of Centromere
antibodies concentration in serum,Anti-SSB (La) Antibodies(Anti-SSB
(La) Antibodies)-Reagents for measurement of SSB concentration in
serum,Autoantibodies RL/RK/RS (AA-RL/RK/RS)(Autoantibodies
RL/RK/RS (AA-RL/RK/RS))-Reagents for measurement of auto
antibodies concentration in serum,Anti-Endomysium Antibodies (AEA)
(Anti-Endomysium Antibodies (AEA))-Reagents for measurement of
Endomysium antibodies concentration in serum,Anti-Neutrophil
Cytoplasmic Antibodies (ANCA)(Anti-Neutrophil Cytoplasmic
Antibodies (ANCA))-Reagents for measurement of ANCA
concentration in serum,Anti-nDNA Antibodies (nDNA)(Anti-nDNA
Antibodies (nDNA))-Reagents for measurement of nDNA
concentration in serum,Anti-Nuclear Antibodies HEp-2 (ANA-HEp-2)
(Anti-Nuclear Antibodies HEp-2 (ANA-HEp-2))-Reagents for
measurement of ANA Hep2 in serum,Prevecal ANCA(Prevecal
ANCA)-External quality Control to verify the performance of the
measurement procedure,Prevecal Celiac(Prevecal Celiac)-External

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
quality Control to verify the performance of the measurement
procedure,Prevecal nDNA(Prevecal nDNA)-External quality Control to
verify the performance of the measurement procedure,Prevecal
ANA(Prevecal ANA)-External quality Control to verify the performance
of the measurement procedure,Prevecal Proteins(Prevecal Proteins)-
External quality Control to verify the performance of the measurement
procedure,Prevecal Rheuma(Prevecal Rheuma)-External quality
Control to verify the performance of the measurement
procedure,Prevecal Biochemistry Human(Prevecal Biochemistry
Human)-External quality Control to verify the performance of the
measurement procedure,Prevecal Biochemistry(Prevecal
Biochemistry)-External quality Control to verify the performance of the
measurement procedure,Rheumatoid Control Serum II(Rheumatoid
Control Serum II)-Control to verify the performance of the
measurement procedure,Rheumatoid Control Serum I(Rheumatoid
Control Serum I)-Control to verify the performance of the
measurement procedure,Protein Control Serum II(Protein Control
Serum II)-Control to verify the performance of the measurement
procedure,Protein Control Serum I(Protein Control Serum I)-Control to
verify the performance of the measurement procedure,Lipid Control
Serum II(Lipid Control Serum II)-Control to verify the performance of
the measurement procedure,Lipid Control Serum I(Lipid Control
Serum I)-Control to verify the performance of the measurement
procedure,Biochemistry Control Urine(Biochemistry Control Urine)-
Control to verify the performance of the measurement
procedure,Biochemistry Control Serum (Human) II(Biochemistry
Control Serum (Human) II)-Control to verify the performance of the
measurement procedure,Biochemistry Control Serum (Human)
I(Biochemistry Control Serum (Human) I)-Control to verify the
performance of the measurement procedure,Biochemistry Control
Serum II(Biochemistry Control Serum II)-Control to verify the
performance of the measurement procedure,Biochemistry Control
Serum I(Biochemistry Control Serum I)-Control to verify the
performance of the measurement procedure,ADA Controls(ADA
Controls)-Control to verify the performance of the measurement

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
procedure,Rheumatoid Factors ( RF ) Standard(Rheumatoid Factors (
RF ) Standard)-Being used to standardize the RF kit,Protein ( Urine )
standard(Protein ( Urine ) standard)-Being used to standardize the
Protein urine kit,Protein Calibrators(Protein Calibrators)-Being used to
standardize the Immunoturbidimetry kits.,Homocysteine
Standards(Homocysteine Standards)-Being used to standardize the
Homocysteine kit,Hemoglobin A1C –Direct ( HbA1C-Dir )
Standards(Hemoglobin A1C –Direct ( HbA1C-Dir ) Standards)-Being
used to standardize the HbA1C kit,Ferritin Standard(Ferritin
Standard)-Being used to standardize the Ferritin kit,CRP-er
Standard(CRP-er Standard)-Being used to standardize the CRP er
kit.,Homocysteine(Homocysteine)-Reagents for measurement of
homocysteine concentration in serum,Hemoglobin A1C Direct (
HbA1C-Dir )(Hemoglobin A1C Direct ( HbA1C-Dir ))-Reagents for
measurement of HbA1C direct concentration in serum,Glucose-
Hexokinase(Glucose-Hexokinase)-Reagents for measurement of
glucose hexokinase concentration in serum,LKM POSITIVE
CONTROL(LKM POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,GBMA POSITIVE
CONTROL(GBMA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,ATA POSITIVE
CONTROL(ATA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,AStMA POSITIVE
CONTROL(AStMA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,ASA-is POSITIVE
CONTROL(ASA-is POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,ASA-bm POSITIVE
CONTROL(ASA-bm POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,APCA POSITIVE
CONTROL(APCA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,AKA POSITIVE
CONTROL(AKA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,AICA POSITIVE
CONTROL(AICA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,AACA POSITIVE

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
CONTROL(AACA POSITIVE CONTROL)-Control to verify the
performance of the measurement procedures,C-REACTIVE PROTEIN
(CRP) CONTROL +(C-REACTIVE PROTEIN (CRP) CONTROL +)-
Control to verify the performance of the measurement
procedures,RHEUMATOID FACTORS (RF) CONTROL +
(RHEUMATOID FACTORS (RF) CONTROL +)-Control to verify the
performance of the measurement procedures,ANTI-STREPTOLYSIN
O (ASO) CONTROL +(ANTI-STREPTOLYSIN O (ASO) CONTROL +)-
Control to verify the performance of the measurement
procedures,OXALATE CONTROL URINE II(OXALATE CONTROL
URINE II)-Control to verify the performance of the measurement
procedures,Oxalate Pretreatment Reagents(Oxalate Pretreatment
Reagents)-Reagents for measurement of Oxalate concentration in
serum,Zinc Standard(Zinc Standard)-Being used to standardize the
Zinc kit,Fructose Standard(Fructose Standard)-Being used to
standardize the Fructose kit,Washing Solution(Washing Solution)-
Washing solution being used to clean the internal part of the
instrument,Phosphorus Standard(Phosphorus Standard)-Being used
to standardize the Phosphorus kit,C-Reactive Protein (CRP) –
Slide(C-Reactive Protein (CRP) – Slide)-Reagents for measurement
of CRP concentration in serum,Anti-Streptolysin O (ASO) – Slide(Anti-
Streptolysin O (ASO) – Slide)-Reagents for measurement of ASO
concentration in serum,Anti-Insulin Antibodies (INS)(Anti-Insulin
Antibodies (INS))-Reagents for measurement of Insulin concentration
in serum,Anti-Thyroglobulin Antibodies (Anti-Tg)(Anti-Thyroglobulin
Antibodies (Anti-Tg))-Reagents for measurement of Thyroglobulin
concentration in serum,Anti-Thyroid Peroxidase Antibodies (Anti-TPO)
(Anti-Thyroid Peroxidase Antibodies (Anti-TPO))-Reagents for
measurement of Thyroperoxidase concentration in serum,ASCA –
IgG/IgA (ASCA)(ASCA –IgG/IgA (ASCA))-Reagents for measurement
of ASCA concentration in serum,Anti-Deamidated Gliadin peptides IgA
( DGP – IgA)(Anti-Deamidated Gliadin peptides IgA ( DGP – IgA))-
Reagents for measurement of Deaminated Gliadin IgA concentration
in serum,Anti-Deamidated Gliadin peptides IgG ( DGP – IgG)(Anti-
Deamidated Gliadin peptides IgG ( DGP – IgG))-Reagents for

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
measurement of Deaminated Gliadin IgG concentration in serum,Anti-
Gliadin Antibodies (AGA-IgG/IgA)(Anti-Gliadin Antibodies (AGA-
IgG/IgA))-Reagents for measurement of Gliadin concentration in
serum,Anti-tTransglutaminase IgG Antibodies ((Anti-tTG IgG)(Anti-
tTransglutaminase IgG Antibodies ((Anti-tTG IgG))-Reagents for
measurement of tTG IgG concentration in serum,Anti-
tTransglutaminase IgA Antibodies (Anti-tTG IgA)(Anti-
tTransglutaminase IgA Antibodies (Anti-tTG IgA))-Reagents for
measurement of tTG IgA concentration in serum,Anti-GBM antibodies
–EIA (GBM)(Anti-GBM antibodies –EIA (GBM))-Reagents for
measurement of GBM concentration in serum,Anti-MPO
Antibodies(Anti-MPO Antibodies)-Reagents for measurement of MPO
concentration in serum,Anti-PR3 Antibodies(Anti-PR3 Antibodies)-
Reagents for measurement of Proteinase3 concentration in
serum,Anti-Annexin V IgG/IgM (ANX)(Anti-Annexin V IgG/IgM (ANX))-
Reagents for measurement of Annexin concentration in serum,Anti-
B2-Glycoprotein 1 IgG/IgM (B2-GP1)(Anti-B2-Glycoprotein 1 IgG/IgM
(B2-GP1))-Reagents for measurement of Beta 2 Glycoprotein
concentration in serum,Anti-Phospholipid IgG/IgM (APLA)(Anti-
Phospholipid IgG/IgM (APLA))-Reagents for measurement of
phospholipids concentration in serum,Anti-Cardiolipin Antibodies
(ACA-IgG/IgM)(Anti-Cardiolipin Antibodies (ACA-IgG/IgM))-Reagents
for measurement of cardiolipin concentration in serum,Anti-SSA (Ro)
Antibodies(Anti-SSA (Ro) Antibodies)-Reagents for measurement of
SSA concentration in serum,Anti-Sm/RNP Antibodies(Anti-Sm/RNP
Antibodies)-Reagents for measurement of Sm concentration in
serum,Anti-Sm Antibodies(Anti-Sm Antibodies)-Reagents for
measurement of Nrnp/Sm concentration in serum,ENA 4-Profile(ENA
4-Profile)-Reagents for measurement of a ENA Antibodies
concentration in serum,ENA 6-Screening(ENA 6-Screening)-Reagents
for measurement of a ENA Antibodies concentration in serum,ANA-
Screening(ANA-Screening)-Reagents for measurement of Anti nuclear
antibodies concentration in serum,P ANCA Positive control(P ANCA
Positive control)-Control to verify the performance of the
measurement procedure,CANCA Positive control(CANCA Positive

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
control)-Control to verify the performance of the measurement
procedure,nDNA Positive control(nDNA Positive control)-Control to
verify the performance of the measurement procedure,ASMA Positive
control(ASMA Positive control)-Control to verify the performance of
the measurement procedure,AMA Positive control(AMA Positive
control)-Control to verify the performance of the measurement
procedure,AEA Positive control(AEA Positive control)-Control to verify
the performance of the measurement procedure,ANA Sp Positive
control(ANA Sp Positive control)-Control to verify the performance of
the measurement procedure,ANA Nu Positive control(ANA Nu Positive
control)-Control to verify the performance of the measurement
procedure,ANA Ce Positive control(ANA Ce Positive control)-Control
to verify the performance of the measurement procedure,ANA Ho
Positive control(ANA Ho Positive control)-Control to verify the
performance of the measurement procedure,Negative
control(Negative control)-Control to verify the performance of the
measurement procedure,Mounting Medium(Mounting Medium)-
Auxilliary reagent being used for the measurement of autoimmune
parameters in serum,PBS (10x)(PBS (10x))-Auxilliary reagent being
used for the measurement of autoimmune parameters in serum,IgG
FITC/EVANS(IgG FITC/EVANS)-Auxilliary reagent being used for the
measurement of autoimmune parameters in serum,FITC/EVANS ( R )
(FITC/EVANS ( R ))-Auxilliary reagent being used for the
measurement of autoimmune parameters in serum,IgA
FITC/EVANS(IgA FITC/EVANS)-Auxilliary reagent being used for the
measurement of autoimmune parameters in serum,IgG FITC/EVANS
(M)(IgG FITC/EVANS (M))-Auxilliary reagent being used for the
measurement of autoimmune parameters in serum,Autoantibodies
Duo-Hep2/ML(DUO-HEP2/ML)(Autoantibodies Duo-Hep2/ML(DUO-
HEP2/ML))-Reagents for measurement of ANA concentration in
serum,Anti-Keratin Antibodies (AKA)(Anti-Keratin Antibodies (AKA))-
Reagents for measurement of keratin antibodies concentration in
serum,Anti-Skin Antibodies (ASA)(Anti-Skin Antibodies (ASA))-
Reagents for measurement of skin antibodies concentration in
serum,Anti-Thyroid Antibodies (ATA)(Anti-Thyroid Antibodies (ATA))-

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Reagents for measurement of Thyroid antibodies concentration in
serum,Anti-Islet Cell Antibodies (AICA)(Anti-Islet Cell Antibodies
(AICA))-Reagents for measurement of islet cell antibodies
concentration in serum,Anti-striated Muscle Antibodies (AStMA)(Anti-
striated Muscle Antibodies (AStMA))-Reagents for measurement of
AstMA concentration in serum,Anti-Adrenal Cortex Antibodies (AACA)
(Anti-Adrenal Cortex Antibodies (AACA))-Reagents for measurement
of Adrenal cortex antibodies concentration in serum,Glomerular
Basement Membrane Antibodies (GBMA)(Glomerular Basement
Membrane Antibodies (GBMA))-Reagents for measurement of GBM
concentration in serum,Anti-Smooth Muscle Antibodies (ASMA)(Anti-
Smooth Muscle Antibodies (ASMA))-Reagents for measurement of
Anti smooth muscle antibodies concentration in serum,Anti-
Mitochondrial Antibodies (AMA)(Anti-Mitochondrial Antibodies (AMA))-
Reagents for measurement of Mitochondrial antibodies concentration
in serum,Autoantibodies-MsL/MsK/MsS (AA-MsL/MsK/MsS)
(Autoantibodies-MsL/MsK/MsS (AA-MsL/MsK/MsS))-Reagents for
measurement of auto antibodies concentration in
serum,Homocysteine control II(Homocysteine control II)-Control to
verify the performance of the measurement procedure,Homocysteine
control I(Homocysteine control I)-Control to verify the performance of
the measurement procedure,Hemoglobin A2 Control(Hemoglobin A2
Control)-Control to verify the performance of the measurement
procedure,Hemoglobin A1C Control(Elevated)(Hemoglobin A1C
Control(Elevated))-Control to verify the performance of the
measurement procedure,Fertility Biochemistry Control(Fertility
Biochemistry Control)-Control to verify the performance of the
measurement procedure,CK-MB Control Serum II(CK-MB Control
Serum II)-Control to verify the performance of the measurement
procedure,CK-MB Control Serum I(CK-MB Control Serum I)-Control to
verify the performance of the measurement procedure,CRP / CRP –
Hs standard(CRP / CRP – Hs standard)-Being used to standardize the
CRP/hsCRP kits,Creatinine Kinase – MB ( CKMB )
Standard(Creatinine Kinase – MB ( CKMB ) Standard)-Being used to
standardize the CKMB kit,Cholesterol HDL/LDL Calibrator(Cholesterol

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
HDL/LDL Calibrator)-Being used to standardize the HDL/LDL
kits,Bilirubin Standard(Bilirubin Standard)-Being used to standardize
the bilirubin kit,Biochemistry Calibrator (Human)(Biochemistry
Calibrator (Human))-Being used to standardize the biochemical
parameters,Biochemistry Calibrator(Biochemistry Calibrator)-Being
used to standardize the biochemical parameters,Apolipoprotein B
Standard(Apolipoprotein B Standard)-Being used to standardize the
APO B kit,Apolipoprotein A-I Standard(Apolipoprotein A-I Standard)-
Being used to standardize the APO A1 kit,Anti – streptolysin O ( ASO )
Standard(Anti – streptolysin O ( ASO ) Standard)-Being used to
standardize the ASO kit,Albumin ( Microalbuminuria )
Standard(Albumin ( Microalbuminuria ) Standard)-Being used to
standardize the Microalbuminurea kit,Adenosine deaminase ( ADA )
Standard(Adenosine deaminase ( ADA ) Standard)-Being used to
standardize the ADA kit,Vanilmandelic Acid(Vanilmandelic Acid)-
Reagents for measurement of Vanilmandelic acid concentration in
urine,Metanephrines(Metanephrines)-Reagents for measurement of
Metanephrines concentration in urine,17-Ketosteroids(17-
Ketosteroids)-Reagents for measurement of 17-Ketosteroides
concentration in urine,17-Hydroxycoricosteroids(17-
Hydroxycoricosteroids)-Reagents for measurement of 17-OH
concentration in urine,5-Hydroxyindoleacetic Acid (5-HIAA)(5-
Hydroxyindoleacetic Acid (5-HIAA))-Reagents for measurement of 5-
H1AA concentration in urine,Hemoglobin A2(Hemoglobin A2)-
Reagents for measurement of Hemoglobin A2 concentration in
urine,Control Urine(Control Urine)-Control to verify the performance of
the measurement procedure,5-Aminolevulinic Acid (ALA) /
Porphobilinogen (PBG)(5-Aminolevulinic Acid (ALA) / Porphobilinogen
(PBG))-Reagents for measurement of 5-ALA PBG concentration in
urine,Zinc(Zinc)-Reagents for measurement of Zinc concentration in
serum,Uric Acid(Uric Acid)-Reagents for measurement of Uric acid
concentration in serum,Urea/Bun-UV(Urea/Bun-UV)-Reagents for
measurement of Urea BUN UV concentration in serum,Urea/Bun-
Color(Urea/Bun-Color)-Reagents for measurement of Urea BUN
Colour concentration in serum,Triglycerides(Triglycerides)-Reagents

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
for measurement of Triglycerides concentration in
serum,Transferrin(Transferrin)-Reagents for measurement of
Transferrin concentration in serum,Total Iron Binding Capacity (TIBC)
(Total Iron Binding Capacity (TIBC))-Reagents for measurement of
TIBC concentration in serum,Total Bile Acids(Total Bile Acids)-
Reagents for measurement of total bile acids concentration in
serum,Rheumatoid Factors (RF)(Rheumatoid Factors (RF))-Reagents
for measurement of Rheumatoid factors concentration in
serum,Protein (Urine)(Protein (Urine))-Reagents for measurement of
Protein urine concentration in urine,Protein (Total)(Protein (Total))-
Reagents for measurement of Protein Total concentration in
serum,Prealbumin(Prealbumin)-Reagents for measurement of
Prealbumin concentration in serum,Phosphorus(Phosphorus)-
Reagents for measurement of Phosphorus concentration in
serum,Magnesium(Magnesium)-Reagents for measurement of a
Magnesium concentration in serum,Lipase(Lipase)-Reagents for
measurement of Lipase concentration in serum,Lactate
Dehydrogenase (LDH) – IFCC(Lactate Dehydrogenase (LDH) –
IFCC)-Reagents for measurement of LDH IFCC concentration in
serum,Lactate Dehydrogenase (LDH)(Lactate Dehydrogenase
(LDH))-Reagents for measurement of LDH concentration in
serum,Lactate(Lactate)-Reagents for measurement of lactate
concentration in serum,Iron-Ferrozine(Iron-Ferrozine)-Reagents for
measurement of Iron ferrozine concentration in serum,Iron-
Chromazurol(Iron-Chromazurol)-Reagents for measurement of Iron
chromazoul concentration in serum,Immunoglobulin M (IgM)
(Immunoglobulin M (IgM))-Reagents for measurement of IgM
concentration in serum,urine,Immunoglobulin G (IgG)(Immunoglobulin
G (IgG))-Reagents for measurement of IgG concentration in
serum,urine,Immunoglobulin A (IgA)(Immunoglobulin A (IgA))-
Reagents for measurement of IgA concentration in serum,
urine,Glucose(Glucose)-Reagents for measurement of glucose
concentration in serum,g-Glutamyltransferase (g-GT)(g-
Glutamyltransferase (g-GT))-Reagents for measurement of GGT
concentration in serum,Fructose(Fructose)-Reagents for

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measurement of Fructose concentration in
serum,Fructosamine(Fructosamine)-Reagents for measurement of
Fructosamine concentration in serum,Ferritin(Ferritin)-Reagents for
measurement of Ferritin concentration in serum,Creatinine
Enzymatic(Creatinine Enzymatic)-Reagents for measurement of
Creatinine Enzymatic concentration in serum,Creatinine(Creatinine)-
Reagents for measurement of Creatinine concentration in
serum,Creatine Kinase-MB (CK-MB)(Creatine Kinase-MB (CK-MB))-
Reagents for measurement of creatine kinase MB concentration in
serum,Creatine Kinase (CK)(Creatine Kinase (CK))-Reagents for
measurement of creatine kinase concentration in serum,C-Reactive
Protein-er (CRP-er)(C-Reactive Protein-er (CRP-er))-Reagents for
measurement of CRP er concentration in serum,C-Reactive Protein
hs (CRP-hs)(C-Reactive Protein hs (CRP-hs))-Reagents for
measurement of CRP hs concentration in serum,C-Reactive Protein
(CRP)(C-Reactive Protein (CRP))-Reagents for measurement of CRP
concentration in serum,Complement Component C4(Complement
Component C4)-Reagents for measurement of C4 concentration in
serum,Complement Component C3(Complement Component C3)-
Reagents for measurement of C3 concentration in
serum,Citrate(Citrate)-Reagents for measurement of Citrate
concentration in serum,Cholinesterase (CHE)(Cholinesterase (CHE))-
Reagents for measurement of Cholinesterase concentration in
serum,Cholesterol LDL Precipitating Reagent(Cholesterol LDL
Precipitating Reagent)-Reagents for measurement of Cholesterol LDL
Precipitating reagent concentration in serum,Cholesterol HDL
Precipitating Reagent(Cholesterol HDL Precipitating Reagent)-
Reagents for measurement of Cholesterol HDL Precipitating reagent
concentration in serum,Cholesterol HDL(Cholesterol HDL)-Reagents
for measurement of Cholesterol HDL concentration in
serum,Cholesterol HDL Direct(Cholesterol HDL Direct)-Reagents for
measurement of Cholesterol HDL Direct concentration in
serum,Apolipoprotein B (Apo B)(Apolipoprotein B (Apo B))-Reagents
for measurement of APO B concentration in serum,Apolipoprotein A-I
(Apo A-I)(Apolipoprotein A-I (Apo A-I))-Reagents for measurement of

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APO A1 concentration in serum,Anti-Streptolysin O (ASO)(Anti-
Streptolysin O (ASO))-Reagents for measurement of ASO
concentration in serum,Angiotensin Converting Enzyme ( ACE )
(Angiotensin Converting Enzyme ( ACE ))-Reagents for measurement
of ACE concentration in serum,Alkaline Phosphatase (ALP)-
DEA(Alkaline Phosphatase (ALP)-DEA)-Reagents for measurement of
alkaline phosphatase DEA concentration in serum,Alkaline
Phosphatase (ALP)-AMP(Alkaline Phosphatase (ALP)-AMP)-
Reagents for measurement of alkaline phosphatase AMP
concentration in serum,Albumin (Microalbuminuria)(Albumin
(Microalbuminuria))-Reagents for measurement of microalbuminurea
concentration in serum, plasma, Urine

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607 IMP/IVD/2019/000428 BioSystems Fibrinogen Standard(Fibrinogen Standard)-Being used to standardize CDSCO Class C
Diagnostics Pvt. the Fibrinogen kit,Coagulation Control I(Coagulation Control I)-Control
Ltd. to verify the performance of the measurement procedure,Coagulation
Calibrator(Coagulation Calibrator)-Being used to standardize the
coagulation kits,Thrombin Time ( TT )(Thrombin Time ( TT ))-
Reagents for measurement of clot formation in blood,Fibrinogen
clauss(Fibrinogen clauss)-Reagents for measurement of clot
formation in blood,Activated Partial Thromboplastin Time ( APTT )
(Activated Partial Thromboplastin Time ( APTT ))-Reagents for
measurement of clot formation in blood,Prothrombin Time ( PT )
(Prothrombin Time ( PT ))-Reagents for measurement of clot
formation in blood.,Fibrinogen(Fibrinogen)-Reagents for measurement
of Fibrinogen concentration in serum,Beta 2 microglobulin
controls(Beta 2 microglobulin controls)-Control to verify the
performance of the measurement procedure,Carbon Dioxide ( Co2 )
(Carbon Dioxide ( Co2 ))-Reagents for measurement of co2
concentration in serum,Fibrinogen control plasma(Fibrinogen control
plasma)-Control to verify the performance of the measurement
procedure,Beta 2 microglobulin(Beta 2 microglobulin)-Reagents for
measurement of Beta2 microglobulin concentration in serum,Beta 2
microglobulin control urine(Beta 2 microglobulin control urine)-Control
to verify the performance of the measurement
procedure,KAPPA/LAMBDA CALIBRATOR(KAPPA/LAMBDA
CALIBRATOR)-Being used to standardize the Kappa/Lambda
kit,Lambda(Lambda)-Reagents for measurement of Ethanol
concentration in serum,Kappa(Kappa)-Reagents for measurement of
Kappa concentration in serum,Beta 2 microglobulin standard(Beta 2
microglobulin standard)-Being used to standardize the Beta 2
microglobulin kit,Ammonia/ethanol/co2 control
L2(Ammonia/ethanol/co2 control L2)-Control to verify the performance
of the measurement procedure,Ammonia/ethanol/co2 control
L1(Ammonia/ethanol/co2 control L1)-Control to verify the performance
of the measurement procedure,Ammonia/ethanol/co2
calibrator(Ammonia/ethanol/co2 calibrator)-Being used to standardize
the Ammonia, Ethanol & CO2 kit,Coagulation Control II(Coagulation
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Control II)-Control to verify the performance of the measurement
procedure

608 IMP/IVD/2019/000429 M/S. Histofluor® Rodent LKS Fluorescent Antibody Test CDSCO Class B
MEDSOURCE System(Histofluor®)-This is an indirect fluorescent antibody test for
OZONE the qualitative and semi-quantitative detection of IgG autoantibodies in
BIOMEDICALS human serum by manual fluorescent microscopy or with the Image
PVT LTD Navigator® Fluorescence Semi-Automated Microscope. This test
system is to be used as an aid in the detection of anti-mitochondrial
(AMA), anti-parietal cell (APCA), and anti-smooth muscle (ASMA)
autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary
Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in
conjunction with other laboratory and clinical findings. A trained
operator must confirm results generated with the Image Navigator®
semi-automated device and software.,ANCA Formalin Fluorescent
Test System(Immuno Concepts or IC)-Indirect Fluorescent antibody
test for the semi quantitative detection of antineutrophil cytoplasmic
auto antibodies (ANCA) in human serum on formalin fixed slide,PBS
Powder(Immuno Concepts (IC))-Phosphate Buffered Saline (PBS)
used for rinsing/washing slides and microwell strips in Immunoassay
test system such as Ana - RO Test system,ANA Sample
Diluent(Immuno Concepts or IC)-Buffer used as a diluent for patient
samples/Serum in Ana - RO Test System,ANCA Ethanol Fluorescent
Test System(Immuno Concepts or IC)-Indirect Fluorescent antibody
test for the semi quantitative detection of antineutrophil cytoplasmic
auto antibodies (ANCA) in human serum on ethanol fixed slide,nDNA
Fluorescent Test System(Immunoconcepts or IC)-Indirect fluorescent
antibody test for the semi quantitative detection of anti- nDNA
antibody in human serum,ANA-RO IgG Fluorescent Test System(Hep
2000(R))-INDIRECT FLUORESCENT ANTIBODY TEST FOR THE
SEMI - QUANTITATIVE DETECTION OF IGG ANTINUCLEAR
ANTIBODY (ANA) IN HUMAN SERUM

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609 IMP/IVD/2019/000431 Beckman Coulter iChem 10SG Urine Chemistry Strips (iChem 10SG Urine Chemistry CDSCO Class B
India Private Strips )-The iChem100 Urine Chemistry Analyzer (iChem100) is a
Limited Hisaria semi-automated benchtop urine chemistry analyzer intended for the in
Warehouse vitro measurement of the following analytes: glucose, protein, bilirubin,
Ground Floor urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte
esterase, ascorbic acid, and color. The iChem100 is intended for use
only with iChem 10 SG Urine Chemistry Strips and is intended for use
exclusively by healthcare professionals.,iChem VELOCITY Urine
Chemistry Strips (iChem VELOCITY Urine Chemistry Strips )-The
iChemVELOCITY Strips are manufactured for use only with the
iChemVELOCITY Urine Chemistry system and are intended for use
exclusively by healthcare professionals. These qualitative or semi-
quantitative measurements can be used along with other diagnostic
tools in the evaluation of renal, urinary, and metabolic
disorders.,vChem 10SG Urine Chemistry Strips (vChem 10SG Urine
Chemistry Strips )-vChem Urine Chemistry Strips are intended for in
vitro measurement of the following analytes in urine: glucose, protein,
bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite,
leukocytes, and ascorbic acid. vChem Urine Chemistry Strips are
intended for visual use only.

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610 IMP/IVD/2019/000432 Siemens RAPIDLab 1265(RAPIDLab 1265)-RAPIDLab 1200 systems are CDSCO Class A
Healthcare intended for in vitro diagnostic use by healthcare professionals in the
Private Limited quantitative testing of human whole blood. The systems can
determine the following parameters: System Parameters 1240 pH,
pCO2, pO2 1245 pH, pCO2, pO2, tHb, nBili, FO2Hb, FCOHb,
FMetHb, FHHb 1260 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose,
lactate 1265 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate,
tHb, nBili, FO2Hb, FCOHb, FMetHb, FHHb ,DCA Vantage(DCA
Vantage)-The DCA Vantage system is a semi-automated, benchtop
system. It is designed to quantitatively measure the percent of
Hemoglobin A1c in blood and low concentrations of albumin in urine
(microalbuminuria), creatinine in urine, and the albumin/creatinine
ratio in urine. The DCA Vantage system is intended for professional
use in a physician’s office or hospital laboratory. Tests performed
using the DCA Vantage system are intended for in vitro diagnostic
use. As with all diagnostic tests, do not base a definitive diagnosis on
the results of a single test. A physician should make a diagnosis after
all clinical and laboratory findings are evaluated. The system is a
spectrophotometer that analyzes the intensity of the light transmitted
through the cartridge optical window and reports the results in
clinically meaningful units. No calculations are required by the user.
When you swipe a calibration card, the barcode reader reads the card
and the system automatically performs the calibration. ,CLINITEK
Status + Urine Chemistry Analyzer(CLINITEK Status + Urine
Chemistry Analyzer)-The CLINITEK Status+ Urine Chemistry Analyzer
is a portable semi-automated, easy to use analyzer. It is designed to
read only Siemens Healthcare Diagnostics Reagent Strips for
Urinalysis and Clinitest® hCG tests. This analyzer is intended for the
semi-quantitative and qualitative type of measurement of the following
in human urine: Albumin, Bilirubin, Blood (Occult), Creatinine,
Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-
Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity,
Urobilinogen, and human Chorionic Gonadotropin (hCG). These
measurements are used to aid in assessment of conditions such as: •
kidney disease • Urinary tract infections • Metabolic disorders (such as
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diabetes mellitus) • Liver disease • Pregnancy Tests performed using
the CLINITEK Status+ analyzer are intended for in vitro diagnostic use
only. The CLINITEK Status+ analyzer is intended for professional use
in near patient (point-of-care) facilities and centralized laboratory
locations. ,CLINITEK Novus® Automated Urine Chemistry
Analyzer(CLINITEK Novus® Automated Urine Chemistry Analyzer)-
The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully
automated urinalysis instrument, intended for professional in vitro
diagnostic use in centralized laboratory locations. The CLINITEK
Novus Analyzer is intended to read Siemens Healthcare Diagnostics
CLINITEK Novus cassettes, as well as determine urine specific gravity
and urine clarity. The CLINITEK Novus cassettes are intended for the
semi-quantitative measurement of the following parameters in human
urine samples: albumin, bilirubin, blood (occult), creatinine, glucose,
ketone (acetoacetic acid), leukocytes, nitrite (qualitative), pH, protein,
color, urobilinogen, albumin-to-creatinine ratio, and protein-to-
creatinine ratio. These measurements are used to aid in assessment
of conditions such as: • Carbohydrate metabolism (such as diabetes
mellitus) • Kidney disease • Liver disease • Metabolic disorders •
Urinary tract infection For in vitro diagnostic use. ,RAPIDLab
348EX(RAPIDLab 348EX)-The system is designed for the
determination of pH, pCO2, pO2, Na+, K+, Ca++ or Cl– and Hct in
heparinized human whole blood samples. The minimum sample
volume is 50 μL. The results appear on the touch screen display in pH
or H+, mmHg or kPa for pCO2 and pO2, mmol/L for Na+, K+, Ca++ or
Cl–, and % for Hct. The system also calculates the following
parameters: • Standard and actual bicarbonate (HCO3–std and
HCO3–act) • Total carbon dioxide content (ctCO2) • Blood and extra-
cellular fluid base excess (BE(B) and BE (ecf)) • Estimated oxygen
saturation (O2SAT) • Estimated oxygen content (O2CT) • Arterial-
alveolar oxygen tension difference (pO2(A–a)) and arterial-alveolar
oxygen tension ratio (pO2(a/A)) • Anion gap (AnGap) • Estimated total
hemoglobin (ctHb(est)) • Calcium ion concentration adjusted to pH 7.4
(Ca++(7.4)) • Arterial oxygen tension-inspired oxygen fraction ratio
(pO2/FIO2) The system is also designed for routine determination of

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pH, pCO2, Na+, K+, and Ca++ in acetate- and bicarbonate-based
dialysis fluids. When used in dialysis fluid mode, the results are
displayed on the touch screen in pH or H+, mmHg or kPa for pCO2,
and mmol/L for Na+, K+, and Ca++. In dialysis fluid mode, the system
calculates the following parameters: actual bicarbonate (HCO3–act)
and total carbon dioxide content (ctCO2). ,RAPIDPoint
500e(RAPIDPoint 500e)-The RAPIDPoint® 500e Blood Gas system is
intended for in vitro diagnostic use and is designed to provide the
determination in whole blood for the following parameters: • Partial
pressure of carbon dioxide • Partial pressure of oxygen • pH • Sodium
• Potassium • Ionized calcium • Chloride • Glucose • Lactate • Total
hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb • Neonatal
bilirubin The RAPIDPoint 500e Blood Gas System is also intended for
in vitro testing of pleural fluid samples for the pH parameter. The pH
measurement of pleural fluid can be a clinically useful tool in the
management of patients with parapneumonic effusions. The following
critical value applies to pleural fluid pH: pH > 7.3 is measured in
uncomplicated parapneumonic effusions. All pleural fluids with a pH
measurement < 7.3 are referred to as complicated parapneumonic
effusions, and are exudative in nature. This test system is intended for
professional use in point-of-care or laboratory settings.

611 IMP/IVD/2019/000432 Siemens ADVIA Centaur Wash 1(ADVIA Centaur Wash 1)-ADVIA Centaur CDSCO Class B
Healthcare Wash 1 is a system fluid used for washing cuvettes between reaction
Private Limited steps. For some assays, it is used for particle resuspension.

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612 IMP/IVD/2019/000432 Siemens 6.8/7.3 Buffer Pack(6.8/7.3 Buffer Pack)-Provides the calibration point CDSCO Class C
Healthcare for pH, electrolyte and hematocrit calibrations,RAPIDPoint® 405
Private Limited Measurement Cartridge(RAPIDPoint® 405 Measurement Cartridge)-
The RAPIDPoint 405 Measurement cartridges are intended for use in
In Vitro-diagnostics and are intended for determination in pleural fluid
samples for the pH parameter: PO2, PCO2, pH, Sodium, Potassium,
ionized calcium, chloride, Glucose & Total hemoglobin and fractions:
FO2Hb, FCOHb, FHHb.,Hematocrit (HCT) Slope
Ampoules(Hematocrit (HCT) Slope Ampoules)-Intended to provide the
slope point for Hct calibration during the in vitro diagnostic procedures
on pH/Blood Gas/Electrolyte Analyzers,AQC Cartridge kit(AQC
Cartridge kit)-For quality control of pH/Blood Gas/Electrolyte
Analyzers,RAPIDPoint®500 Measurement
Cartridge(RAPIDPoint®500 Measurement Cartridge)-The RAPIDPoint
500 Measurement cartridges are intended for use in In Vitro-
diagnostics and are intended for determination in pleural fluid samples
for pH parameter,Conditioner(Conditioner)-Intended to clean and
condition the pH and sodium sensors of the pH/Blood Gas/Electrolyte
Analyzer,RAPIDLab® 1200 pH Electrode Fill Solution(RAPIDLab®
1200 pH Electrode Fill Solution)-Intended for maintenance of the pH
Electrodes/Sensors of the RapidLab1200 System Series,NA / K / CL
Fill Solution(NA / K / CL Fill Solution)-Intended for maintenance of the
NA/K/CA/CL Electrodes/Sensors of the RapidLab 1200 System
Series,Rapid Lab pH Sensor Fill Solution(Rapid Lab pH Sensor Fill
Solution)-Intended for maintenance of the pH Electrodes/Sensors of
the RapidLab1200 System Series,RAPIDLab® 1200 Systems
Reagent Cartridge(RAPIDLab® 1200 Systems Reagent Cartridge)-
For the calibration of RapidLab1200 System Series,Reference Sensor
Molar Kcl Saturated with AgCl(Reference Sensor Molar Kcl Saturated
with AgCl)-Intended to maintain a saturated solution of KCL in the
reference sample solution chamber blood gas analyzer,RAPIDLab®
1200 Systems Wash Cartridge(RAPIDLab® 1200 Systems Wash
Cartridge)-Intended to wash the probes and sample paths of the
pH/Blood Gas/Electrolyte Analyzer,RAPID Lab® 1200 Deproteinizer
Pack 10 UDC(RAPID Lab® 1200 Deproteinizer Pack 10 UDC)-
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Intended to remove the protein buildups from the sample paths of the
pH/Blood Gas/Electrolyte Analyzers as part of preventive
maintenance,RAPIDLab® 348EX Cl- Starter Kit(RAPIDLab® 348EX
Cl- Starter Kit)-Intended to support the initialization of RAPIDLab
348EX Blood Gas Analyzer,RAPIDLab® 348EX Ca++ Starter
Kit(RAPIDLab® 348EX Ca++ Starter Kit)-To Support the Initialization
of RAPIDLab 348EX Blood Gas Analyzer.,Ready Sensor™ GOLD
Reference Sensor Refill(Ready Sensor™ GOLD Reference Sensor
Refill)-Intended to maintain contact with reference electrode to
maintain constant voltage,Rapid Lab Wash and CD Pack(Rapid Lab
Wash and CD Pack)-Intended to wash the probes and sample paths
of the pH/Blood Gas/Electrolyte Analyzer,RAPIDLab® 1200 Electrode
Fill Solution Na+, K+, Ca++, Cl-(RAPIDLab® 1200 Electrode Fill
Solution Na+, K+, Ca++, Cl-)-Intended for maintenance of the
NA/K/K/CA/CL Electrodes/ Sensors of RapidLab 1200 System
Series,RAPID Point 400/405/500 Wash/Waste Cartridge Kit(RAPID
Point 400/405/500 Wash/Waste Cartridge Kit)-Intended to clean the
sample path and waste fluid without contacting system components
for RAPIDPoint 400/500 series systems.,Ready sensor gold reference
sensor inner (Ready sensor gold reference sensor inner )-KCl solution
for use in contact with potassium electrode.,RAPIDLab® 1200 Series
CO-ox Sample Chamber(RAPIDLab® 1200 Series CO-ox Sample
Chamber)-For in vitro diagnostic use in the measurement of the total
hemoglobin and hemoglobin fractions in the human samples using
Rapid lab Systems,Reference Electrode Fill Solution(Reference
Electrode Fill Solution)-The Reference Electrode Fill Solution is an in
vitro diagnostic medical device for use with RAPIDLab® series
analyzers. ,Ready Sensor™ GOLD Potassium Sensor(Ready
Sensor™ GOLD Potassium Sensor)-The Ready Sensor™ GOLD
Potassium Sensor is an in vitro diagnostic medical device for use with
RAPIDLab® series analyzers.,Reference Sensor Refill (Cassette/ Fill
Solution) Kit(Reference Sensor Refill (Cassette/ Fill Solution) Kit)-The
Reference Sensor Refill is an in vitro diagnostic medical device for
use with RAPIDLab® series analyzers.,6.8/7.3 Buffer(6.8/7.3 Buffer)-
The 6.8/7.3 Buffer is an in vitro diagnostic medical device for use with

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RAPIDLab® series analyzers.,Ready Sensor™ GOLD pH
Sensor(Ready Sensor™ GOLD pH Sensor)-The Ready Sensor™
GOLD pH Sensor is an in vitro diagnostic medical device for use with
RAPIDLab® series analyzers.,Sodium (Na+) electrode IVD(Sodium
(Na+) electrode IVD)-The Sodium (Na+) electrode IVD is an in vitro
diagnostic medical device for use with RAPIDLab® series
analyzers.,Ready Sensor™ GOLD Chloride Sensor(Ready Sensor™
GOLD Chloride Sensor)-The Ready Sensor™ GOLD Chloride Sensor
is an in vitro diagnostic medical device for use with RAPIDLab® series
analyzers.

613 IMP/IVD/2019/000434 Roche Cyclosporine Sample Pretreatment reagent(Cyclosporine Sample CDSCO Class C
Diagnostics India Pretreatment reagent)-The COBAS INTEGRA Cyclosporine Sample
Pvt. Ltd. Pretreatment Reagent is an in vitro diagnostic reagent intended for
use with the COBAS INTEGRA Cyclosporine assay on the COBAS
INTEGRA analyzers as an alternative to methanolic extraction of
samples.,Cyclosporine Calibrator 0 ng/mL(Cyclosporine Calibrator 0
ng/mL)-Cyclosporine Calibrator 0 ng/mL is for use in the calibration of
the quantitative determination of cyclosporine using the COBAS
INTEGRA Cyclosporine reagent on COBAS INTEGRA
analyzers.,ACET2 Calibrator(ACET2 Calibrator)-ACET2 calibrator is
for use in the calibration of the Acetaminophen Gen 2 Roche
assay.,Cyclosporine Calibrators(Cyclosporine Calibrators)-
Cyclosporine Calibrators is for use in the calibration of quantitative
determination of cyclosporine using the COBAS INTEGRA
Cyclosporine reagent on COBAS INTEGRA analyzers.

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614 IMP/IVD/2019/000435 IRIS Diatro●Diff-5P(DIATRON)-Used for quantitative determination of CDSCO Class B

HEALTHCARE leukocytes (WBC) and leukocyte 5-part differentiation (LYM, MONO,
TECHNOLOGIES NEU, EO, BA) measurement.,Diatro●Hypoclean CC(DIATRON)-Used
PRIVATE for Hard Cleaning procedure to remove protein and lipids from sample
LIMITED tubes, chambers and apertures.,Diatro●Hypoclean(DIATRON)-
Optional reagent. Used for service maintenance for removing debris
from tubing and chambers.,Diatro Cleaner(DIATRON)-Used to clean
the tubing, counting chambers and apertures.,Diatro Dil-
5P(DIATRON)-Used to dilute whole blood samples and rinse the fluidi
system between measuring cycles.,Diatro Lyse 5P(DIATRON)-Used
as lysing agent for stromatolysis of erythrocytes (RBC), for
quantitative determination of leukocytes (WBC), leukocyte 5-part
differentiation (LYM, MONO, NEU, EO, BA) and hemoglobin (HGB)
concentration measurement in human blood.,Diatro●Dil-
DIFF(DIATRON)-Used to dilute whole blood samples and rinse the
fluidi system between measuring cycles.,Diatrocal Hematology
Calibrator(DIATRON)-Used for performing calibration of Icount3
CP.,Diatro Lyse-DIFF(DIATRON)-Used for creating the hemolysates
for 3-part WBC differential, total WBC count and HGB determination.

615 IMP/IVD/2019/000436 Ascensia Blood Glucose Test Strips(Contour)-Contour Test Strips are intended CDSCO Class B
Diabetes Care for self- testing by people with diabetes and by health care
India Pvt. Ltd. professionals to monitor glucose concentrations in whole blood.

616 IMP/IVD/2019/000437 Beckman Coulter MicroScan Prompt Inoculation System-D(MicroScan Prompt CDSCO Class B
India Private Inoculation System-D)-The Prompt inoculation systems-D is used to
Limited Hisaria standardize inocula for micro dilution antimicrobial susceptibility tests.
Warehouse
Ground Floor

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

617 IMP/IVD/2019/000438 Fujifilm India FUJI DRI CHEM SLIDE LDH-P III(FUJI DRI CHEM SLIDE LDH-P III)- CDSCO Class B
Private Limited Use for the quantitative measurment of Lactate dehydrogenase
activity in plasma or serum,FUJI DRI CHEM SLIDE ALB-P(FUJI DRI
CHEM SLIDE ALB-P)-Use for the quantitative measurement of
albumin concentration in plasma or serum,FUJI DRI CHEM SLIDE
BUN-P III(FUJI DRI CHEM SLIDE BUN-P III)-Use for the quantitative
measurment of Urea nitrogen concentration in plasma or serum,FUJI
DRI CHEM SLIDE HDL-C-P III D(FUJI DRI CHEM SLIDE HDL-C-P III
D)-Use for the quantitative measurment of high density lipoprotin
cholestrol in plasma or serum,FUJI DRI CHEM Diluent DL (CRP)(FUJI
DRI CHEM Diluent DL (CRP))-For in-vitro blood testing purposes,FUJI
DRI CHEM CONTROL QP-H(FUJI DRI CHEM CONTROL QP-H)-For
in-vitro blood testing purposes,FUJI DRI CHEM CONTROL QN(FUJI
DRI CHEM CONTROL QN)-For in-vitro blood testing purposes,FUJI
DRI CHEM ELECTROLYTE CONTROL QE(FUJI DRI CHEM
ELECTROLYTE CONTROL QE)-For in-vitro blood testing
purposes,FUJI DRI CHEM REFERENCE FLUID RE(FUJI DRI CHEM
REFERENCE FLUID RE)-For in-vitro blood testing purposes,FUJI
DRI CHEM CALIBRATOR CP (CRP)(FUJI DRI CHEM CALIBRATOR
CP (CRP))-To calibrate C-reactive protein test ,FUJI DRI CHEM
SLIDE NA-K-CL(FUJI DRI CHEM SLIDE NA-K-CL)-Use for the
quantitative measurment of sodium, potassium and chloride in
concentration in whole blood, plasma or serum,FUJI DRI CHEM
SLIDE TCO2-P(FUJI DRI CHEM SLIDE TCO2-P)-Use for the
quantitative measurment of total carbon dioxide (Co2) concentration in
plasma or serum,FUJI DRI CHEM CONTROL QP-L(FUJI DRI CHEM
CONTROL QP-L)-For in-vitro blood testing purposes,FUJI DRI CHEM
SLIDE TCHO-P III(FUJI DRI CHEM SLIDE TCHO-P III)-Use for the
quantitative measurment of total Cholesterol concentration in plasma
or serum,FUJI DRI CHEM SLIDE LAP-P(FUJI DRI CHEM SLIDE
LAP-P)-Use for the quantitative measurment of Leucine
aminopeptidase activity in plasma or serum,FUJI DRI CHEM SLIDE
TBIL-P III(FUJI DRI CHEM SLIDE TBIL-P III)-Use for the quantitative
measurment of total bilirubin concentration in plasma or serum,FUJI
DRI CHEM SLIDE NH3-P II(FUJI DRI CHEM SLIDE NH3-P II)-Use for
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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
the quantitative measurment of ammonia concentration in plasma or
serum,FUJI DRI CHEM SLIDE GPT/ALT-P III(FUJI DRI CHEM SLIDE
GPT/ALT-P III)-Use for the quantitative measurment of Glutamic
pyruvic transaminase (alanine aminotransferase) activity in plasma or
serum,FUJI DRI CHEM SLIDE GOT/AST-P III(FUJI DRI CHEM SLIDE
GOT/AST-P III)-Use for the quantitative measurment of Glutamic
oxalacetic transaminase (aspartate aminotransferase) activity in
plasma or serum,FUJI DRI CHEM SLIDE GGT-P III(FUJI DRI CHEM
SLIDE GGT-P III)-Use for the quantitative measurment of Y-
glutamyltranferase activity in plasma or serum,FUJI DRI CHEM SLIDE
CPK-P III(FUJI DRI CHEM SLIDE CPK-P III)-Use for the quantitative
measurment of creatine phosphokinase activity in plasma or
serum,FUJI DRI CHEM SLIDE AMYL-P III(FUJI DRI CHEM SLIDE
AMYL-P III)-Use for the quantitative measurment of amylase activity in
plasma or serum,FUJI DRI CHEM SLIDE CKMB-P(FUJI DRI CHEM
SLIDE CKMB-P)-Use for the quantitative measurment of creatine
phosphokinase isoenzyme MB activity in plasma or serum,FUJI DRI
CHEM SLIDE CHE-P(FUJI DRI CHEM SLIDE CHE-P)-Use for the
quantitative measurment of chloinesterase activity in plasma or
serum,FUJI DRI CHEM SLIDE ALP-P III(FUJI DRI CHEM SLIDE ALP-
P III)-Use for the quantitative measurment of alkaline phosphatise in
plasma or serum,FUJI DRI CHEM SLIDE LIP-P(FUJI DRI CHEM
SLIDE LIP-P)-Use for the quantitative measurment of pancreatic
lipase (LIP) in plasma or serum,FUJI DRI CHEM SLIDE Mg-P III(FUJI
DRI CHEM SLIDE Mg-P III)-Use for the quantitative measurment of
Magnesium concentration in plasma or serum,FUJI DRI CHEM SLIDE
IP-P(FUJI DRI CHEM SLIDE IP-P)-Use for the quantitative
measurment of inorganic phosphorus concentration in plasma or
serum,FUJI DRI CHEM SLIDE DBIL-P II(FUJI DRI CHEM SLIDE
DBIL-P II)-Use for the quantitative measurment of direct bilirubin
concentration in plasma or serum,FUJI DRI CHEM SLIDE TG-P
III(FUJI DRI CHEM SLIDE TG-P III)-Use for the quantitative
measurment of triglyceride Cholesterol concentration in plasma or
serum,FUJI DRI CHEM SLIDE TP-P III(FUJI DRI CHEM SLIDE TP-P
III)-Use for the quantitative measurment of total protein concentration

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
in plasma or serum,FUJI DRI CHEM SLIDE UA-P III(FUJI DRI CHEM
SLIDE UA-P III)-Use for the quantitative measurment of uric acid
concentration in plasma or serum,FUJI DRI CHEM SLIDE GLU-P
III(FUJI DRI CHEM SLIDE GLU-P III)-Use for the quantitative
measurment of glucose concentration in plasma or serum,FUJI DRI
CHEM SLIDE CRP-S III(FUJI DRI CHEM SLIDE CRP-S III)-Use for
the quantitative measurment of human CRP (C-reactive protein)
concentration in plasma or serum,FUJI DRI CHEM SLIDE CRE-P
III(FUJI DRI CHEM SLIDE CRE-P III)-Use for the quantitative
measurment of creatine concentration in plasma or serum,FUJI DRI
CHEM SLIDE Ca-P III(FUJI DRI CHEM SLIDE Ca-P III)-Use for the
quantitative measurment of calcium concentration in plasma or serum

618 IMP/IVD/2019/000438 FUJIFILM INDIA FUJI DRI-CHEM IMMUNO AU CARTRIDGE v-T4(FUJI DRI-CHEM CDSCO Class B
Pvt. LTD., IMMUNO AU CARTRIDGE v-T4)-Quantitative measurement of
Thyroxine (T4) concentration in plasma or serum from canine and
feline. ,FUJI DRI-CHEM IMMUNO AU CARTRIDGE vc-TSH(FUJI
DRI-CHEM IMMUNO AU CARTRIDGE vc-TSH)-"Quantitative
measurement of TSH concentration in canine plasma or serum. "
,FUJI DRI-CHEM IMMUNO AU CARTRIDGE v-COR(FUJI DRI-CHEM
IMMUNO AU CARTRIDGE v-COR)-Quantitative measurement of
Cortisol (COR) concentration in canine plasma or serum. ,FUJI DRI-
CHEM IMMUNO AU CARTRIDGE v-BA(FUJI DRI-CHEM IMMUNO
AU CARTRIDGE v-BA)-"Quantitative measurement of Bile acids (BA)
concentration in plasma or serum from canine and feline. " ,FUJI DRI-
CHEM SLIDE vc-CRP-P(FUJI DRI-CHEM SLIDE vc-CRP-P)-
Quantitative measurement of canine CRP(C-reactive-protein)
concentration in plasma or serum. For veterinary use only. ,FUJI DRI-
CHEM SLIDE v-AMY-P(FUJI DRI-CHEM SLIDE v-AMY-P)-
Quantitative measurement of amylase activity in plasma or serum. For
veterinary use only. ,FUJI DRI-CHEM SLIDE v-LIP-P(FUJI DRI-CHEM
SLIDE v-LIP-P)-Quantitative measurement of pancreatic lipase (LIP)
in canine plasma or serum. For veterinary use only.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

619 IMP/IVD/2019/000439 GASTROLAB QuantOn Cal(QuantOn Cal)-QuantOnCal® is an in-vitro diagnostic CDSCO Class B
INDIA PVT. LTD. device (IVD) consisting of an immunological rapid test and a
smartphone app. The QuantOnCal® test system is intended for self-
testing by patients with inflammatory bowel diseases (IBD, e. g.
Crohn’s disease or Ulcerative colitis), who are under the care of a
healthcare practitioner. QuantOnCal® is for the quantitative
determination of the inflammatory marker Calprotectin in faeces and
aids the healthcare practitioner in assessing the inflammatory activity
in the intestine of IBD patients.

620 IMP/IVD/2019/000440 Roche Homocysteine Control Kit (Homocysteine Control Kit)-The CDSCO Class B
Diagnostics India Homocysteine Control Kit is intended for use in quality control by
Pvt. Ltd. monitoring accuracy and precision for the quantitative methods as
specified in the value sheets.,Homocysteine Calibrator Kit
(Homocysteine Calibrator Kit )-The Homocysteine Calibrator Kit is
intended for use in the calibration of quantitative Roche methods on
Roche clinical chemistry analyzers as specified in the value sheets.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

621 IMP/IVD/2019/000441 Anand Brothers FSH IRMA Kit(FSH IRMA kit)-Immunoradiometric assay for the in vitro CDSCO Class B
Determination of fsh in human serum and Plasma. For in vitro
diagnostic use,LH IRMA Kit(LH IRMA kit)-Immunoradiometric assay
for the in vitro determination of luteinizing hormone in human serum
and plasma. For in vitro diagnostic use.,Estradiol RIA Kit(Estradiol RIA
Kit)-Radioimmunoassay for the in vitro determination of estradiol in
human serum and plasma. For in vitro diagnostic use. ,Total T4 RIA
kit(Total T4 RIA kit)-Radioimmunoassay for the in vitro determination
of free total thyroxine (TT4) in human serum and plasma. For in vitro
diagnostic use.,FT4 RIA Kit(FT4 RIA KIT)-Radioimmunoassay for the
in vitro determination of free thyroxine in human serum and plasma.
For in vitro diagnostic use.,TSH IRMA KIT(TSH IRMA KIT)-
Immunoradiometric assay for the in vitro determination of thyroid-
stimulating hormone in human serum and plasma. For in vitro
diagnostic use.,Unconjugated Estriol(Unconjugated Estriol)-
Radioimmunoassay for the in vitro Determination of unconjugated
estriol in Human serum. For in vitro diagnostic use.,PTH IRMA kit(PTH
IRMA Kit)-Immunoradiometric assay for the in vitro determination of
parathyroid hormone in human serum and plasma. For in vitro
diagnostic use.,ACTH IRMA Kit(ACTH IRMA Kit)-Immunoradiometric
assay for the in vitro Determination of ACTH in human plasma. For in
vitro diagnostic use.,FT3 RIA Kit(FT3 RIA Kit)-Radioimmunoassay for
the in vitro determination of free triiodothyronine in human serum and
plasma. For in vitro diagnostic use.,Ferritin IRMA Kit(Ferritin IRMA
Kit)-Immunoradiometric assay for the in vitro Determination of ferritin
in human serum and Plasma. For in vitro diagnostic use.,Cortisol RIA
kit(Cortisol RIA kit)-Radioimmunoassay for the in vitro determination of
cortisol in human serum, plasma and urine. For in vitro diagnostic
use.,Aldosterone RIA Kit(Aldosterone RIA Kit)-Radioimmunoassay for
the in vitro determination of aldosterone in human serum, plasma and
urine. For in vitro diagnostic use.,25-OH Vitamin D Total RIA kit(25-OH
Vitamin D Total RIA kit)-Radioimmunoassay for the in vitro
determination of 25-hydroxyvitamin D3 and D2 (25-OH-D3 and 25-
OH-D2) in human serum. For in vitro diagnostic use.,Testosterone
Direct RIA kit(Testosterone Direct RIA Kit)-Radioimmunoassay for the
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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
in vitro determination of total testosterone in human serum and
plasma. For in vitro diagnostic use.,Anti-hTg IRMA kit(Anti-hTg IRMA
kit)-Immunoradiometric assay for the in vitro Determination of Anti-hTg
in human serum and plasma. For in vitro diagnostic
use.,Dihydrotestosterone (Active (R) DHT)(Dihydrotestosterone
(Active (R) DHT))-Radioimmunoassay for the in vitro quantitative
measurement of dihydrotestosterone (DHT) in human serum or
plasma. For in vitro diagnostic use.,DHEA Sulfate Kit(DHEA Sulfate
Kit)-Radioimmunoassay for the in vitro determination of
dehydroepiandrosterone sulfate in human serum and plasma. For in
vitro diagnostic use.,C-Peptide IRMA(C-Peptide IRMA)-
Immunoradiometric assay for the in vitro Determination of c-peptide in
human serum, Plasma and urine. For in vitro diagnostic use.,SHBG
IRMA kit(SHBG IRMA kit)-Immunoradiometric assay for the in vitro
Determination of sex hormone binding Globulin in human serum. For
in vitro diagnostic use.,17 α-Hydroxyprogesterone RIA kit(17 α-
Hydroxyprogesterone RIA kit)-Radioimmunoassay for the in vitro
determination of 17α-hydroxyprogesterone in human serum and
plasma. For in vitro diagnostic use.,Active(R) IGFBP-3 IRMA
kit(Active(R) IGFBP-3 IRMA kit)-Immunoradiometric kit for the
quantitative measurement of IGFBP-3 in human serum. This assay is
intended for in vitro diagnostic use.,Anti - TPO RIA KIT(Anti - TPO RIA
KIT)-Radioimmunoassay for the in vitro determination of antibodies
against thyroid peroxidase (anti-TPO) in human serum. For in vitro
diagnostic use.,DHEA RIA Kit(DHEA RIA Kit)-Radioimmunoassay for
the in vitro determination of dehydroepiandrosterone in human serum
or plasma. For in vitro diagnostic use.,Estrone RIA Kit(Estrone RIA
kit)-Radioimmunoassay for the quantitative measurement of estrone in
human serum or plasma. This assay is intended for in vitro diagnostic
use.,Prolactin IRMA kit(Prolactin IRMA kit)-Immunoradiometric assay
for the in vitro Determination of prolactin in human serum and plasma.
For in vitro diagnostic use.,Progesterone RIA kit(Progesterone RIA
Kit)-Radioimmunoassay for the in vitro determination of progesterone
in human serum and plasma. For in vitro diagnostic
use.,Androstenedione RIA(Androstenedione RIA)-Radioimmunoassay

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kit for the quantitative measurement of androstenedione in human
serum or plasma. This assay is intended for in vitro diagnostic
use.,Insulin IRMA kit(Insulin IRMA kit)-Immunoradiometric assay for
the in vitro Determination of insulin in human serum and Plasma. For
in vitro diagnostic use.,Total T3 RIA Kit(Total T3 RIA Kit)-
Radioimmunoassay for the in vitro determination of total
triiodothyronine (TT3) in human serum and plasma. For in vitro
diagnostic use.,IGF-1 IRMA Kit(IGF-1 IRMA Kit)-Immunoradiometric
assay for the in vitro determination of insulin–like growth factor I in
human serum and plasma. For in vitro diagnostic use.,Active Free
Testosterone RIA kit(Active Free Testosterone RIA kit)-
Radioimmunoassay for the quantitative measurement of free
testosterone in human serum. This assay is intended for in vitro
diagnostic use.,Albumin RIA kit(Albumin RIA Kit)-Radioimmunoassay
for in vitro determination of albumin in human urine. For in vitro
diagnostic use.,GH IRMA Kit(GH IRMA Kit)-Immunoradiometric assay
for the in vitro determination of growth hormone in human serum and
plasma. For in vitro diagnostic use.,Angiotensin I (Plasma Renin
Activity) RIA Kit(Angiotensin I (Plasma Renin Activity) RIA Kit)-
Radioimmunoassay of angiotensin I for the in vitro determination of
plasma renin activity (PRA) in human plasma. For in vitro diagnostic
use.

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622 IMP/IVD/2019/000444 Abbott Vysis Protease I(Vysis Protease I)-It is used to prepare the specimen CDSCO Class A
Healthcare Pvt. for the use in fluorescence in situ hybridization (FISH) with Vysis DNA
Ltd. probes.,Vysis CEP Hybridization Buffer(Vysis CEP Hybridization
Buffer)-Vysis CEP Hybridization Buffer is a solution containing sodium
chloride, sodium citrate and dextran sulfate in formamide. It is used to
reconstitute Vysis chromosome enumerator probe (CEP) DNA probes
to facilitate the hybridization of the probe to the target DNA.,Vysis
IntelliFISH Hybridization Buffer (Vysis IntelliFISH Hybridization Buffer
)-The Vysis IntelliFISH Hybridization Buffer is used with fluorescence
in situ hybridization (FISH) probes to facilitate FISH hybridization of
the Vysis FISH probes to the target and facilitates hybridization within
1-3 hours, allowing laboratories to generate FISH results in a single
day.,Vysis IntelliFISH Hybridization Buffer (Vysis IntelliFISH
Hybridization Buffer )-The Vysis IntelliFISH Hybridization Buffer is
used with fluorescence in situ hybridization (FISH) probes to facilitate
FISH hybridization of the Vysis FISH probes to the target and
facilitates hybridization within 1-3 hours, allowing laboratories to
generate FISH results in a single day.,Vysis LSI/WCP Hybridization
Buffer(Vysis LSI/WCP Hybridization Buffer)-Vysis LSI/WCP
Hybridization Buffer is a solution containing sodium chloride, sodium
citrate and dextran sulfate in formamide. It is used to reconstitute
Vysis locus specific identifier (LSI) DNA probes to facilitate the
hybridization of the probe to the target DNA.,Antifade II
Solution(Antifade II Solution)-Antifade II is a mounting solution that is
used to prevent the rapid photobleaching of AMCA, Texas Red,
rhodamine, fluorescein, and other fluorochromes,DAPI III
Counterstain (DAPI III Counterstain )-DAPI III Counterstain in antifade
mounting solution is a mixture containing 4’,6-diamino-2 phenylindole
and 1,4-pheylenediamine in a phosphate buffered saline and
glycerol,Vysis Paraffin Pretreatment Reagent Kit(Vysis Paraffin
Pretreatment Reagent Kit)-To prepare paraffin-embedded tissue
sections fixed on positively charged slides for the use in fluorescence
in situ hybridization (FISH) with Vysis probes.,VP 2000 Pretreatment
Reagent(VP 2000 Pretreatment Reagent)-VP 2000 Reagents are
specifically designed for automated deparaffinization and pretreatment
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protocols for Vysis FISH assays,Antifade Solution(Antifade Solution)-
Antifade Solution is a mounting solution containing a mixture of 1,4-
pheylenediamine in a phosphate buffered saline and glycerol. ,Vysis
IntelliFISH Universal FFPE Tissue Pretreatment Protease (Vysis
IntelliFISH Universal FFPE Tissue Pretreatment Protease )-Vysis
IntelliFISH Universal FFPE Tissue Pretreatment and Wash Reagent
Kit and Vysis IntelliFISH Universal FFPE Tissue Pretreatment
Protease (For 500 mL) are used to prepare formalin-fixed, paraffin-
embedded tissue sections fixed on positively charged slides for the
use in fluorescence in situ hybridization (FISH) with Vysis DNA FISH
probes. This is for automated assay on VP2000 Processor. ,VP 2000
Reagents Protease Buffer(VP 2000 Reagents Protease Buffer)-VP
2000 Reagents are specifically designed for automated
deparaffinization and pretreatment protocols for Vysis FISH assays.
The Protease Buffer is 0.01N hydrochloride acid. ,Protease
II(Protease II)-It is used to prepare the specimen for the use in
fluorescence in situ hybridization (FISH) with Vysis DNA probes on
VP2000 Processor.,Proteinase K, Recombinant, PCR Grade(Abbott
Proteinase K)- The general purpose reagent contains proteinase K,
Recombinant, PCR Grade, from Pichia pastoris.,Microscope slide
maker/stainer(VP 2000 Processor)-The Abbott VP 2000 Processor is
a device designed to automate and standardize slide specimen
processing including deparaffinization, FISH pretreatment and routine
slide staining for the laboratory. The unit is preprogrammed to perform
slide pretreatment protocols for FISH assays and can be programmed
to perform routine histology/cytology slide staining or routine slide
washing according to user requirements.,Uracil-N-Glycosylase (UNG)
(Uracil-N-Glycosylase (UNG))-Uracil-N-glycosylase is to be used in
conjunction with the Abbott RealTime assays as an optional
contamination control for customer laboratories that are currently
using or have previously used amplification technologies that
incorporate uracil into the amplification product. ,DAPI I Counterstain
(DAPI I Counterstain )-DAPI Counterstain in antifade mounting
solution is a mixture containing 4’,6-diamino-2 phenylindole and 1,4-
pheylenediamine in a phosphate buffered saline and glycerol mixture.

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When used as a counterstain in FISH assays, the DAPI appears as a
vivid blue color on interphase and metaphase cells.,20X SSC(20X
SSC)-20X SSC, 500g (Saline Sodium Citrate) is a salt powder mixture
containing sodium chloride and sodium citrate. It is used to make 20X
SSC solution and subsequent dilutions for denaturing and wash
solutions.,NP-40(NP-40)-NP-40 is a non-ionic surfactant that is used
in the aqueous post-hybridization wash solution,Vysis FISH
Pretreatment Reagent Kit(Vysis FISH Pretreatment Reagent Kit)-To
prepare cells recovered from urine pellets fixed onto slides for use in
fluorescence in situ hybridization (FISH) with Vysis probes.,Vysis
IntelliFISH Universal FFPE Tissue Pretreatment and Wash
Reagents(Vysis IntelliFISH Universal FFPE Tissue Pretreatment and
Wash Reagents)-Vysis IntelliFISH Universal FFPE Tissue
Pretreatment and Wash Reagent Kit, Vysis IntelliFISH Universal FFPE
Tissue Pretreatment Protease (For 50 mL) and Vysis IntelliFISH
Universal FFPE Tissue Pretreatment Protease (For 500 mL) are used
to prepare formalin-fixed, paraffin-embedded tissue sections fixed on
positively charged slides for use in fluorescence in situ hybridization
(FISH) with Vysis DNA FISH probes.,Vysis IntelliFISH Universal FFPE
Tissue Pretreatment Protease (for 50 mL)(Vysis IntelliFISH Universal
FFPE Tissue Pretreatment Protease (for 50 mL))-Vysis IntelliFISH
Universal FFPE Tissue Pretreatment and Wash Reagent Kit and Vysis
IntelliFISH Universal FFPE Tissue Pretreatment Protease (For 50 mL)
are used to prepare formalin-fixed, paraffin-embedded tissue sections
fixed on positively charged slides for use in fluorescence in situ
hybridization (FISH) with Vysis DNA FISH probes. This is for manual
assay.,DAPI II Counterstain (DAPI II Counterstain )-DAPI II
Counterstain in antifade mounting solution is a mixture containing 4’,6-
diamino-2 phenylindole and 1,4-pheylenediamine in a phosphate
buffered saline and glycerol mixture. When used as a counterstain in
FISH assays, the DAPI appears as a vivid blue color on interphase
and metaphase cells.

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623 IMP/IVD/2019/000444 Abbott Vysis LSI PML/RARA Dual Color Dual Fusion Probes(Vysis LSI CDSCO Class B
Healthcare Pvt. PML/RARA Dual Color Dual Fusion Probes)-Vysis LSI PML/RARA
Ltd. Dual Color Dual Fusion Probes hybridizes to chromosome 15q22-24
(PML SpectrumOrange) and chromosome 17q21 (Retinoic Acid
Receptor α SpectrumGreen). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI 1p36 SpectrumOrange/1q25
SpectrumGreen Probes and Vysis LSI 19q13 SpectrumOrange/19p13
SpectrumGreen Probes(Vysis LSI 1p36 SpectrumOrange/1q25
SpectrumGreen Probes and Vysis LSI 19q13 SpectrumOrange/19p13
SpectrumGreen Probes)-Vysis LSI 1p36 SpectrumOrange/1q25
SpectrumGreen Probes and Vysis LSI 19q13 SpectrumOrange/19p13
SpectrumGreen Probes consist of two separate probe mixtures: one
probe set/vial contains LSI 1p36 SpectrumOrange and LSI 1q25
SpectrumGreen, and the other probe set/vial contains LSI 19q13
SpectrumOrange and LSI 19p13 SpectrumGreen. The hybridized
probes fluoresce with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes.,Vysis LSI CBFB Dual Color
Break Apart Rearrangement Probe(Vysis LSI CBFB Dual Color Break
Apart Rearrangement Probe)-Vysis LSI CBFB Dual Color Break Apart
Rearrangement Probe hybridizes to the band 16q22 (SpectrumRed on
the centromeric side and SpectrumGreen on the telomeric side of the
CBF gene breakpoint). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI MLL Dual Color Break Apart
Rearrangement Probe(Vysis LSI MLL Dual Color Break Apart
Rearrangement Probe)-Vysis LSI MLL Dual Color Break Apart
Rearrangement Probe hybridizes to the band 11q23 (SpectrumGreen
on the centromeric side and SpectrumOrange on the telomeric side of
the MLL gene breakpoint). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI BCL6 Dual Color Break Apart
Rearrangement Probe(Vysis LSI BCL6 Dual Color Break Apart
Rearrangement Probe)-Vysis LSI BCL6 Dual Color Break Apart DNA
probe hybridizes to the band 3q27. The 5’ BCL6 SpectrumOrange™
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probe is ~349 kb in size and flanks the ABR of BCL6. The 3’ BCL6
SpectrumGreen™ probe is approximately 600kb in size and flanks the
MBR region of BCL6. There is an approximate 269 kb gap between
the two probes.,Vysis LSI IGH Dual Color Break Apart Rearrangement
Probe(Vysis LSI IGH Dual Color Break Apart Rearrangement Probe)-
Vysis LSI IGH Dual Color Break Apart Rearrangement Probe
hybridizes to the band 14q32.3 (SpectrumGreen on the telomeric side
and SpectrumOrange on the centromeric side of the IGH locus
breakpoints). The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis LSI BCL2 Dual Color Break Apart
Rearrangement Probe(Vysis LSI BCL2 Dual Color Break Apart
Rearrangement Probe)-Vysis LSI BCL2 Dual Color Break Apart
Rearrangement Probe hybridizes to the band 18q21 (SpectrumGreen
on the 3’ (centromeric) side and SpectrumOrange on the 5’ (telomeric)
side of the BCL 2 locus breakpoints). The hybridized probe fluoresces
with moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI BCR/ABL1/ASS1Tri-color Dual
Fusion Probes(Vysis LSI BCR/ABL1/ASS1Tri-color Dual Fusion
Probes)-Vysis LSI BCR/ABL1/ASS1Tri-color Dual Fusion Probes
hybridize to chromosome 22q11.2 (breakpoint cluster region -
Spectrum Green), chromosome 9q34 (ABL1 oncogene - Spectrum
Orange and ASS1 gene locus - Spectrum Aqua). The hybridized
probe fluoresces with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes.,Vysis LSI BCR/ABL Dual
Color Dual Fusion Probes(Vysis LSI BCR/ABL Dual Color Dual Fusion
Probes)-Vysis LSI BCR/ABL Dual Color Dual Fusion Probes
hybridizes to chromosome 22q11.2 (breakpoint cluster region
SpectrumGreen) and to chromosome 9q34 (abl oncogene
SpectrumOrange). The hybridized probe fluoresces with moderate to
bright intensity both in interphase nuclei and on metaphase
chromosomes,Vysis LSI IGH/MAF Dual Color Dual Fusion
Probes(Vysis LSI IGH/MAF Dual Color Dual Fusion Probes)-Vysis LSI
IGH/MAF Dual Color Dual Fusion Probes hybridize to chromosome
14q32 (IGH SpectrumGreen) and chromosome 16q23 (MAF

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SpectrumOrange). The hybridized probe fluoresces with moderate to
bright intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis LSI TP53 SpectrumOrange/ CEP 17
SpectrumGreen Probe(Vysis LSI TP53 SpectrumOrange/ CEP 17
SpectrumGreen Probe)-Vysis LSI TP53 SpectrumOrange/CEP 17
SpectrumGreen Probes hybridize to chromosome 17. The
SpectrumOrange TP53 probe hybridizes to 17p13.1. The probe is 170
kb in size and covers the entire TP53 gene. The CEP 17 is labeled in
SpectrumGreen and hybridizes to the 17p11.1-q11.1 region of
chromosome 17,Vysis LSI IGH/FGFR3 Dual Color Dual Fusion
Probes(Vysis LSI IGH/FGFR3 Dual Color Dual Fusion Probes)-Vysis
LSI IGH/FGFR3 Dual Color Dual Fusion Probes hybridize to
chromosome 14q32 (IGH SpectrumGreen) and chromosome 4p16
(FGFR3 SpectrumOrange). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes,Vysis LSI IGH/BCL2 Dual Color Dual
Fusion Probes(Vysis LSI IGH/BCL2 Dual Color Dual Fusion Probes)-
Vysis LSI IGH/BCL2 Dual Color Dual Fusion Probes hybridize to
chromosome 14q32 (IGH SpectrumGreen) and chromosome 18q21
(BCL2 SpectrumOrange). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes,Vysis LSI D20S108 (20q12)
SpectrumOrange Probe(Vysis LSI D20S108 (20q12) SpectrumOrange
Probe)-Vysis LSI D20S108 (20q12) SpectrumOrange DNA probe
hybridizes to band 20q12, locus D20S108 on human chromosome 20.
The hybridized probe fluoresces with moderate to bright intensity both
in interphase nuclei and on metaphase chromosomes.,Vysis LSI
EGFR SpectrumOrange/CEP 7 SpectrumGreen Probes(Vysis LSI
EGFR SpectrumOrange/CEP 7 SpectrumGreen Probes)-Vysis LSI
EGFR SpectrumOrange/CEP 7 SpectrumGreen Probes hybridize to
the band region 7p11.2 - 7p12 in SpectrumOrange and the
centromere of chromosome 7 (7p11.1-q11,1, D7Z1 locus) in
SpectrumGreen. The hybridized probe fluoresces with moderate to
bright intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis LSI ETV6 (TEL) / RUNX1 (AML1) ES Dual Color

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Single Fusion Probe(Vysis LSI ETV6 (TEL) / RUNX1 (AML1) ES Dual
Color Single Fusion Probe)-Vysis LSI ETV6 (TEL) / RUNX1 (AML1)
ES Dual Color Single Fusion Probe hybridizes to chromosome 12p13
(SpectrumGreen TEL - ETV6) and to chromosome 21q22
(SpectrumOrange AML1). The hybridized probe fluoresces with bright
intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis LSI IGH/CCND1 Dual Color Dual Fusion
Probes(Vysis LSI IGH/CCND1 Dual Color Dual Fusion Probes)-Vysis
LSI IGH/CCND1 Dual Color Dual Fusion Probes hybridize to
chromosome 14q32.3 (IgH SpectrumGreen) and chromosome 11q13
(CCND1 SpectrumOrange). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI MYC Dual Color Break Apart
Rearrangement Probe(Vysis LSI MYC Dual Color Break Apart
Rearrangement Probe)-Vysis LSI MYC Dual Color Break Apart
Rearrangement Probe hybridizes to the band region 8q24. The
hybridized probe fluoresces with moderate to bright intensity both in
interphase nuclei and on metaphase chromosomes.,Alinity m Sample
Prep Kit 2(Alinity m Sample Prep Kit 2)-The Alinity m Sample Prep Kit
2 is used on the automated Alinity m System to isolate nucleic acids
from biological samples for analysis in Polymerase Chain Reaction
(PCR) tests.,Alinity m Sample Prep Kit 1(Alinity m Sample Prep Kit 1)-
The Alinity m Sample Prep Kit 1 is used on the automated Alinity m
System to isolate nucleic acids from biological samples for analysis in
Polymerase Chain Reaction (PCR) tests., CEP 8 Spectrum Orange
DNA Probe Kit( CEP 8 Spectrum Orange DNA Probe Kit)-The CEP 8
Spectrum Orange DNA Probe Kit is intended to detect AT rich alpha
satellite sequences in the centromere region of chromosome 8 in
conjunction with routine diagnostic cytogenetic testing.,ProbeChek
HER-2/neuControl Slides for FISH using PathVysion HER-2DNA
Probe Kit(ProbeChek HER-2/neu Control Slides for FISH using
PathVysion HER-2DNA Probe Kit)-The ProbeChek HER-2/neu Control
Slides are paraffin embedded, fixed,cultured cell specimens applied to
microscope slides. The ProbeChek HER-2/neu Control Slides are
designed for use as FISH assay controls for Appropriate hybridization

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conditions and as controls for proper preparation of reagents during
routine use of the PathVysion HER-2 DNA probes on clinical
specimens.,Vysis CEP X Spectrum Orange/Y Spectrum Green DNA
Probe Kit(Vysis CEP X Spectrum Orange/Y Spectrum Green DNA
Probe Kit)-The CEP X Spectrum Orange / Y Spectrum Green DNA
probe kit is intended to detect alpha satellite sequences in the
centromere region of chromosome X and satellite III DNA at the Yq12
region of chromosome Y in conjunction with routine diagnostic
cytogenetic testing.,ProbeChek Prenatal Positive Control Slides
(ProbeChek Prenatal Positive Control Slides )-The ProbeChek
Prenatal Control slides are fixed cell specimens applied to microscope
slides that are designed for use as controls for interphase FISH, as a
teaching tool for FISH signal enumeration, and for user training and
laboratory quality control.,ANEUVYSION MULTICOLOR DNA PROBE
KIT(ANEUVYSION MULTICOLOR DNA PROBE KIT)-The AneuVysion
(Vysis CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe
Panel is intended to use CEP 18/X/Y probe to detect alpha satellite
sequences in the centromere regions of chromosomes 18, X, and Y,
and LSI 13/21 probe to detect the 13q14 region and the 21q22.13 to
21q22.2 region.,Vysis Paraffin Pretreatment IV & Post-Hybridization
Wash Buffer Kit(Vysis Paraffin Pretreatment IV & Post-Hybridization
Wash Buffer Kit)-To prepare paraffin embedded lung cancer tissue
sections fixed on positively charged slides for use in fluorescence in
situ hybridization (FISH) with Vysis DNA FISH probes.

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624 IMP/IVD/2019/000444 Abbott Real Time HCV Genotype II Amplification Reagent Kit(Abbott Real CDSCO Class C
Healthcare Pvt. Time HCV Genotype II Amplification Reagent Kit)-The Abbott Real
Ltd. Time HCV Genotype II is an in vitro reverse transcription-polymerase
chain reaction (RT-PCR) assay for determining the genotype(s) of
hepatitis C virus (HCV) in plasma and serum from HCV-infected
individuals.,HCV Real Time Control Kit(Abbott Real Time HCV Control
Kit)-The Abbott Real Time HCV Controls are used to establish run
validity of the Abbott Real Time HCV assay when used for the
quantitation of Hepatitis C Virus (HCV) RNA in human serum and
plasma (EDTA) from HCV infected individuals ,Real Time HCV
Genotype II Control Kit(Abbott Real Time HCV Genotype II Control
Kit)-The Abbott RealTime HCV Genotype II Controls are used to
establish run validity of the Abbott Real Time HCV Genotype II assay
when used for determining the genotype(s) of hepatitis C virus (HCV)
in plasma and serum from HCV-infected individuals.,Real Time HIV-1
Qualitative Amplification Reagent Kit(Abbott Real Time HIV-1
Qualitative Amplification Reagent Kit)-The Abbott RealTime HIV-1
Qualitative is an in vitro amplification assay for the qualitative
detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic
acids from human plasma and dried blood spots (DBS).,Real Time
HIV-1 Qualitative Control Kit(Abbott Real Time HIV-1 Qualitative
Control Kit)-The Abbott RealTime HIV-1 Qualitative Controls are used
to establish run validity of the Abbott RealTime HIV-1 Qualitative
assay when used for the qualitative detection of Human
Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human
plasma and dried blood spots (DBS).,HCV Real Time DNA
Quantitation Kit(Abbott Real Time HCV Amplification Reagent Kit)-The
Abbott Real Time HCV assay is an in vitro reverse transcription-
polymerase chain reaction (RT-PCR) assay for the quantitation of
hepatitis C viral ribonucleic acid (HCV RNA) in human serum and
plasma from HCV-infected individuals.,HCV Real Time Calibrator
Kit(Abbott Real Time HCV Calibrator Kit)- The Abbott Real Time HCV
Calibrators are for calibration of the Abbott Real Time HCV assay
when used for the quantitative determination of Hepatitis C Virus
(HCV) RNA in human serum and plasma (EDTA) from HCV infected
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individuals. ,HBV Real Time Calibrator Kit(Abbott Real Time HBV
Calibrator Kit)-The Abbott Real Time HBV Calibrators are for
calibration of the Abbott Real Time HBV assay when used for the
quantitative determination of Hepatitis B Virus (HBV) DNA in human
serum and plasma from HBV infected individuals.,HBV Real Time
Control Kit(Abbott Real Time HBV Control Kit)-The Abbott Real Time
HBV Controls are used to establish run validity of the Abbott Real
Time HBV assay when used for the quantitation of Hepatitis B Virus
(HBV) DNA in human serum and plasma from HBV infected
individuals.,HBV Real Time DNA Quantitation Kit(Abbott Real Time
HBV Amplification Reagent Kit)-Abbott Real Time HBV is an in vitro
polymerase chain reaction (PCR) assay for the quantitation of
Hepatitis B Virus (HBV) DNA in human plasma or serum from
HBV‑infected individuals.,HIV-1 Real Time RNA Quantitation
Kit(Abbott Real Time HIV-1 Amplification Reagent Kit)-The Abbott
Real Time HIV-1 assay is an in vitro reverse transcription polymerase
chain reaction (RT-PCR) assay for the quantitation of Human
Immunodeficiency Virus type 1 (HIV-1) in whole blood spotted on
cards as dried blood spots (DBS) or human plasma from HIV-1
infected individuals.,HIV-1 Real Time Calibrator Kit(Abbott Real Time
HIV-1 Calibrator Kit)-The Abbott Real Time HIV-1 Calibrators are for
calibration of the Abbott Real Time HIV-1 assay when used for the
quantitative determination of human immunodeficiency virus type 1
(HIV-1) RNA in human plasma from HIV-1 infected individuals.,HIV-1
Real Time Control Kit(Abbott Real Time HIV-1 Control Kit)-The Abbott
Real Time HIV-1 Controls are used to establish run validity of the
Abbott Realtime HIV-1 assay when used for the quantitative
determination human immunodeficiency virus type 1 (HIV-1) RNA in
human plasma from HIV-1 infected individuals.,CMV Amplification
Reagent kit(Abbott RealTime CMV Amplification Reagent Kit)-The
Abbott RealTime CMV assay is an in vitro polymerase chain reaction
(PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in
human plasma or whole blood.,CMV Calibrator(Abbott RealTime CMV
Calibrator Kit)-The Abbott RealTime CMV calibrators are for
calibration of the Abbott RealTime CMV assay when used for the

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quantitation of cytomegalovirus (CMV) DNA in human plasma or
whole blood.,CMV Controls(Abbott RealTime CMV Control Kit)-The
Abbott RealTime CMV controls are used to establish run validity of the
Abbott RealTime CMV assay when used for the quantitation of
cytomegalovirus (CMV) DNA in human plasma or whole blood.,CT/NG
Amplification Reagent Kit(Abbott RealTime CT/NG Amplification
Reagent Kit)-The Abbott RealTime CT/NG assay is an in vitro
polymerase chain reaction (PCR) assay for the direct, qualitative
detection of the plasmid DNA for C. trachomatis and the genomic DNA
of N. gonorrhoeae in female endocervical or vaginal swab
specimens.,CT/NG Control(Abbott RealTime CT/NG Control Kit)-The
Abbott RealTime CT/NG Controls are used to establish run validity
and for the qualitative detection of the plasmid DNA of Chlamydia
trachomatis and the genomic DNA of Neisseria gonorrhoeae in female
endocervical or vaginal swab specimens.,PATHVYSION HER-2 DNA
Probe Kit II(PATHVYSION HER-2 DNA Probe Kit II)-The PathVysion
HER-2 DNA Probe Kit II (PathVysion Kit II) is designed to detect
amplification of the HER-2/neu gene via fluorescence in situ
hybridization (FISH) in formalin-fixed, paraffin-embedded human
breast and gastric cancer tissue specimens.,Vysis CLL FISH Probe
Kit(Vysis CLL FISH Probe Kit)-The Vysis CLL FISH Probe Kit is a test
to detect deletion of the LSI TP53, LSI ATM, and LSI D13S319 probe
targets and gain of the D12Z3 sequence probe target via fluorescence
in situ hybridization (FISH) in peripheral blood specimens from
patients with B-cell chronic lymphocytic leukemia
(CLL).,PATHVYSION HER-2 DNA Probe Kit(PATHVYSION HER-2
DNA Probe Kit)-The PathVysion HER-2 DNA Probe Kit (PathVysion
Kit) is designed to detect amplification of the HER-2/neu gene via
fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-
embedded human breast cancer tissue specimens.,Abbott mSample
preparation System DBS Buffer Kit(Abbott mSample preparation
System DBS Buffer Kit)-The Abbott mSample Preparation System
DBS Buffer Kit is used to elute nucleic acid from dried blood
spots.,Alinity m HBV CAL Kit(Alinity m HBV CAL Kit)-The Alinity m
HBV calibrators are for calibration for the Alinity m HBV assay on the

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automated Alinity m System when used for the quantitative
determination of HBV DNA. The calibrators are intended to be used
with the Alinity m HBV assay ,Alinity m HBV AMP Kit(Alinity m HBV
AMP Kit)-The Alinity m HBV assay is an in vitro polymerase chain
reaction (PCR) assay for use with the automated Alinity m System to
quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum.
The Alinity m HBV assay is intended for use as an aid in the
management of patients with chronic HBV infection undergoing anti-
viral therapy. The assay can be used to measure HBV DNA levels at
baseline and during treatment to aid in assessing and monitoring
response to treatment.,Alinity m SARS-COV-2 CTRL Kit(Alinity m
SARS-COV-2 CTRL Kit)-The Alinity m SARS-CoV-2 controls are used
for validity determination of the Alinity m SARS-CoV-2 assay on the
automated Alinity m System. These controls are intended to be used
with the Alinity m SARS-CoV-2 assay; refer to the assay package
insert for additional information.,Alinity m SARS-COV-2 AMP
Kit(Alinity m SARS-COV-2 AMP Kit)-The Alinity m SARS-CoV-2 assay
is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction
(PCR) test intended for the qualitative detection of nucleic acid from
the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP)
swabs collected by a healthcare provider, from patients who are
suspected of COVID-19 infection.,Alinity m HBV CTRL Kit(Alinity m
HBV CTRL Kit)-The Alinity m HBV controls are for validity
determination of the quantitative Alinity m HBV assay on the
automated Alinity m System. These controls are intended to be used
with the Alinity m HBV assay,Alinity m HR HPV CTRL Kit(Alinity m HR
HPV CTRL Kit)-The Alinity m HR HPV controls are for validity
determination of the qualitative Alinity m HR HPV assay on the
automated Alinity m System. These controls are intended to be used
with the Alinity m HR HPV assay,Alinity m HR HPV AMP Kit(Alinity m
HR HPV AMP Kit)-The Alinity m High Risk (HR) HPV assay is a
qualitative in vitro test for use with the automated Alinity m System for
the detection of DNA from 14 high-risk human papillomavirus (HPV)
genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in
clinical specimens. The assay specifically identifies HPV genotypes

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16, 18, and 45 while reporting the concurrent detection of the other
high-risk genotypes (31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68) at
clinically relevant infection levels. The Alinity m HR HPV assay is
intended for the following uses: • To screen patients with ASC-US
(atypical squamous cells of undetermined significance) cervical
cytology test results to determine the need for referral to colposcopy.
The results of this test are not intended to prevent women from
proceeding to colposcopy. • To be used with cervical cytology to
adjunctively screen to assess the presence or absence of high-risk
HPV genotype. • To be used as a first-line primary screening test to
identify women at increased risk for the development of cervical
cancer or the presence of high-grade disease. • To assess the
presence or absence of HPV genotypes 16 and 18 to identify women
at increased risk for the development of cervical cancer or the
presence of high-grade disease with or without cervical cytology.,Vysis
LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/ PML
SpectrumGreen Probes(Vysis LSI SNRPN SpectrumOrange/CEP 15
SpectrumAqua/ PML SpectrumGreen Probes)-The SpectrumOrange
SNRPN probe hybridizes to 15q11.2. The probe is 125 kb in size and
spans the SNRPN gene. The CEP 15 probe is labeled in
SpectrumAqua and hybridizes to the centromeric region of
chromosome 15 and acts as a control probe. The PML
SpectrumGreen probe hybridizes to the 15q22-24 region and is 180
kb in size. The probe may be used with metaphase chromosomes or
interphase nuclei. The signals may also appear diffuse or split
depending upon the condensation of the DNA and the relative
distances between chromatids. The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis D7S486/CEP 7 Fish Probe Kit(Vysis
D7S486/CEP 7 Fish Probe Kit)-The Vysis D7S486/CEP 7 FISH Probe
Kit is a device intended for specimen characterization and detects the
LSI D7S486 probe target on chromosome 7q31 and the CEP 7 probe
target on chromosome 7p11.1-q11.1 in bone marrow and peripheral
blood specimens from patients with acute myeloid leukemia or
myelodysplastic syndrome.,Vysis ALK Break Apart FISH Probe

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Kit(Vysis ALK Break Apart FISH Probe Kit)-The Vysis ALK Break Apart
FISH Probe Kit is a qualitative test to detect rearrangements involving
the ALK gene via fluorescence in situ hybridization (FISH) in formalin-
fixed paraffin-embedded (FFPE) non small cell lung cancer (NSCLC)
tissue specimens to aid in identifying those patients eligible for
treatment with XALKORI® (crizotinib).,Vysis LSI HIRA
SpectrumOrange Probe(Vysis LSI HIRA SpectrumOrange Probe)-The
Vysis LSI HIRA SpectrumOrange fluorescence in situ hybridization
(FISH) probe is targeted to the 22q11.2 region on chromosome 22.
The probe is approximately 117 kb in size and contains part of the
HIRA gene. The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and metaphase
chromosomes.,Vysis Williams Region LSI ELN
SpectrumOrange/D7S486, D7S522 SpectrumGreen Probes(Vysis
Williams Region LSI ELN SpectrumOrange/D7S486, D7S522
SpectrumGreen Probes)-Vysis Williams Region LSI ELN
SpectrumOrange/D7S486, D7S522 SpectrumGreen Probes hybridize
to the band 7q11.2, loci ELN, LIMK1, and D7S613 (SpectrumOrange
LSI Elastin) and to the band 7q31, loci D7S486 and D7S522 of human
chromosome 7. The hybridized probe fluoresces with moderate to
bright intensity both in interphase nuclei and on metaphase
chromosomes,Vysis MET SpectrumRed Probe(Vysis MET
SpectrumRed Probe)-The Vysis LSI MET SpectrumRed fluorescence
in situ hybridization (FISH) probe is targeted to the 7q31.2 region on
chromosome 7. The probe is ~456 kb in size and spans the entire
MET gene. The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis EGR1 FISH Probe Kit-SC (Vysis EGR1 FISH
Probe Kit-SC )-The Vysis EGR1 FISH Probe Kit –SC(Specimen
Characterization) detects the LSI EGR1 probe target on chromosome
5q in bone marrow specimens. The Vysis EGR1 FISH Probe Kit – SC
assay results characterize bone marrow specimens from patients with
acute myeloid leukemia or myelodysplastic syndrome,Vysis LSI TCF3/
PBX1 Dual Color, Dual Fusion Translocation Probe(Vysis LSI TCF3/
PBX1 Dual Color, Dual Fusion Translocation Probe)-Vysis LSI

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TCF3/PBX1 Dual Color, Dual Fusion Translocation Probe hybridizes
to chromosome 19p13.3 (TCF3 - Spectrum Green) and chromosome
1q23 (PBX1 - Spectrum Orange). The PBX1 probe is 635 kb in size
and covers the entire PBX1 gene on chromosome 1q23. The TCF3
probe is 730 kb in size and the green probe extends beyond the TCF3
gene to cover a larger region on chromosome 19p13.3.,Vysis LSI
TRA/D Dual Color Break Apart Rearrangement Probe(Vysis LSI
TRA/D Dual Color Break Apart Rearrangement Probe)-Vysis LSI
TRA/D Dual Color Break Apart Rearrangement Probe hybridizes to
chromosome 14q11.2 in both SpectrumOrange and SpectrumGreen.
The hybridized probe fluoresces with moderate to bright intensity both
in interphase nuclei and on metaphase chromosomes.,Vysis LSI SRY
Spectrum Orange/CEP X Spectrum Green Probes(Vysis LSI SRY
Spectrum Orange/CEP X Spectrum Green Probes)-Vysis LSI SRY
Spectrum Orange/CEP X Spectrum Green Probes hybridize to band
Yp11.3 of the human Y chromosome (LSI SRY SpectrumOrange) and
to the centromere, band region Xp11.1-q11.1, locus DXZ1 (CEP X
SpectrumGreen) of the human X chromosome. The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and on metaphase chromosomes,Vysis LSI DDIT3 (Cen)
SpectrumOrange Probe(Vysis LSI DDIT3 (Cen) SpectrumOrange
Probe)-The Vysis LSI DDIT3 (Cen) SpectrumOrange Probe
fluorescence in situ hybridization (FISH) probe is targeted to the
12q13 region on chromosome 12. The probe is approximately 700 kb
in size and is located centromeric of the DDIT3 gene. The hybridized
probe fluoresces with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes,Abbott RealTime SARS-CoV-
2 Amplification Reagent Kit(Abbott RealTime SARS-CoV-2
Amplification Reagent Kit)-The Abbott RealTime SARS-CoV-2 assay
is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction
(PCR) test intended for the qualitative detection of nucleic acid from
the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP)
swabs from patients who are suspected of COVID-19 by their
healthcare provider.,Abbott RealTime SARS-CoV-2 Control Kit(Abbott
RealTime SARS-CoV-2 Control Kit)-The Abbott RealTime SARS-CoV-

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2 controls are used to establish run validity of the Abbott RealTime
SARS-CoV-2 assay when used for the direct, qualitative detection of
SARS-CoV-2 RNA from nasopharyngeal and oropharyngeal swabs.
,Vysis LSI DDIT3 (Tel) SpectrumGreen Probe(Vysis LSI DDIT3 (Tel)
SpectrumGreen Probe)-The Vysis LSI DDIT3 (Tel) SpectrumGreen
fluorescence in situ hybridization (FISH) probe is targeted to the
12q13 region on chromosome 12. The probe is approximately 663 kb
in size and is located telomeric of the DDIT3 gene. The hybridized
probe fluoresces with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes,Vysis LSI SS18 (Tel)
SpectrumOrange Probe(Vysis LSI SS18 (Tel) SpectrumOrange
Probe)-The Vysis LSI SS18 (Tel) SpectrumOrange fluorescence in situ
hybridization (FISH) probe is targeted to the 18q11.2 region on
chromosome 18. The probe is approximately 650 kb in size and
positioned telomeric to the SS18 gene. The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and metaphase chromosomes.,Vysis LSI SS18 (Cen) SpectrumGreen
Probe(Vysis LSI SS18 (Cen) SpectrumGreen Probe)-The Vysis LSI
SS18 (Cen) SpectrumGreen fluorescence in situ hybridization (FISH)
probe is targeted to the 18q11.2 region on chromosome 18. The probe
is approximately 1044 kb in size and positioned centromeric to the
SS18 gene. The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and metaphase
chromosomes.,Vysis LSI BCR/ABL ES Dual Color Single Fusion
Probes(Vysis LSI BCR/ABL ES Dual Color Single Fusion Probes)-
Vysis LSI BCR/ABL ES Dual Color Single Fusion Probes hybridize to
chromosome 22q11.2 (breakpoint cluster region SpectrumGreen) and
to chromosome 9q34 (abl oncogene SpectrumOrange). The
hybridized probe fluoresces with moderate to bright intensity both in
interphase nuclei and on metaphase chromosomes,Vysis LSI
IGH/MYC/CEP 8 Tri-color Dual Fusion Probes(Vysis LSI
IGH/MYC/CEP 8 Tri-color Dual Fusion Probes)-Vysis LSI
IGH/MYC/CEP 8 Tri-color Dual Fusion Probes reagent hybridizes to
the band 14q32 (IGH) in SpectrumGreen, band 8q24 (MYC) in
SpectrumOrange and the centromere of chromosome 8 in

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SpectrumAqua. The hybridized probe fluoresces with moderate to
bright intensity both in interphase nuclei and on metaphase
chromosomes.,Vysis LSI IGH/BCL2 Dual Color Dual Fusion
Probes(Vysis LSI IGH/BCL2 Dual Color Dual Fusion Probes)-Vysis
LSI IGH/BCL2 Dual Color Dual Fusion Probes hybridize to
chromosome 14q32 (IGH SpectrumGreen) and chromosome 18q21
(BCL2 SpectrumOrange). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI MYB (6q23) SpectrumAqua
Probe(Vysis LSI MYB (6q23) SpectrumAqua Probe)-Vysis LSI MYB
(6q23) SpectrumAqua DNA probe hybridizes to human chromosome
6q23. The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and on metaphase chromosomes.
In interphase nuclei of normal cells, the probe generally appears as
two distinct signals. The probe may also appear as three or four
signals, depending upon DNA condensation, and relative distance
between chromatids. The signals may also appear as diffuse or split
signals. In a normal metaphase, the probe may appear as one or two
signals on each chromosome 6.,Vysis LSI RUNX1 SpectrumGreen
Probe(Vysis LSI RUNX1 SpectrumGreen Probe)-SpectrumGreen
fluorescence in situ hybridization (FISH) probe is targeted to the
21q22 region on chromosome 21. The probe is ~1.4 Mb in size and
spans the entire RUNX1 gene. The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI ETV6 SpectrumOrange
Probe(Vysis LSI ETV6 SpectrumOrange Probe)-The SpectrumOrange
Vysis LSI ETV6 fluorescence in situ hybridization (FISH) probe is
targeted to the 12p13 region on chromosome 12. The probe is ~1.3
Mb in size and spans the entire ETV6 gene. The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and on metaphase chromosomes.,Vysis LSI MALT1 Dual Color Break
Apart Rearrangement Probe(Vysis LSI MALT1 Dual Color Break Apart
Rearrangement Probe)-Vysis LSI MALT1 Dual Color Break Apart
Rearrangement Probe hybridizes to the band 18q21(SpectrumGreen
on the 3’ (telomeric) side and SpectrumOrange on the 5’ (centromeric)

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side of the MALT1 locus breakpoints). The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and on metaphase chromosomes.,Vysis LSI D13S319 (13q14.3)
SpectrumOrange Probe(Vysis LSI D13S319 (13q14.3)
SpectrumOrange Probe)-Vysis LSI D13S319 (13q14.3)
SpectrumOrange DNA probe hybridizes to the band 13q14.3, locus
D13S319 of human chromosome 13. The hybridized probe fluoresces
with bright intensity both in interphase nuclei and on metaphase
chromosomes. In interphase nuclei of normal cells, the probe
generally appears as two distinct signals. Occasionally, it may appear
as three or four signals depending upon the condensation of the DNA
and the relative distances between chromatids. The signals may also
appear diffuse or split. In a normal metaphase, LSI D13S319 may
appear as one or two signals on each chromosome 13.,Vysis LSI
CCND1 (Cen) SpectrumGreen Probe(Vysis LSI CCND1 (Cen)
SpectrumGreen Probe)-The Vysis LSI CCND1 (Cen) SpectrumGreen
fluorescence in situ hybridization (FISH) probe is targeted to the
11q13 region on chromosome 11. The probe is approximately 665 kb
in size and is located centromeric of the CCND1 gene. The hybridized
probe fluoresces with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes,Vysis LSI CCND1 (Tel)
SpectrumOrange Probe(Vysis LSI CCND1 (Tel) SpectrumOrange
Probe)-The Vysis LSI CCND1 (Tel) SpectrumOrange fluorescence in
situ hybridization (FISH) probe is targeted to the 11q13 region on
chromosome 11. The probe is approximately 532 kb in size and
contains the CCND1 gene. The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes.,Vysis LSI FUS (Tel) SpectrumGreen
Probe(Vysis LSI FUS (Tel) SpectrumGreen Probe)-The Vysis LSI FUS
(Tel) SpectrumGreen fluorescence in situ hybridization (FISH) probe is
targeted to the 16p11 region on chromosome 16. The probe is
approximately 505 kb in size and is located telomeric of the FUS
gene. The hybridized probe fluoresces with moderate to bright
intensity both in interphase nuclei and on metaphase
chromosomes,Vysis LSI EWSR1 (22q12) Dual Color Break Apart

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Rearrangement Probe(Vysis LSI EWSR1 (22q12) Dual Color Break
Apart Rearrangement Probe)-Vysis LSI EWSR1 (22q12) Dual Color
Break Apart Rearrangement Probe hybridizes to the band 22q12
(SpectrumGreen on the 3’ (telomeric) side and SpectrumOrange on
the 5’ (centromeric) side of the EWSR1 gene breakpoints). The
hybridized probe fluoresces with moderate to bright intensity both in
interphase nuclei and on metaphase chromosomes,Vysis LSI FUS
(Cen) SpectrumOrange Probe(Vysis LSI FUS (Cen) SpectrumOrange
Probe)-The SpectrumOrange Vysis LSI FUS (Cen) fluorescence in
situ hybridization (FISH) probe is targeted to the 16p11 region on
chromosome 16. The probe is approximately 275 kb in size and is
located centromeric of the FUS gene. The hybridized probe fluoresces
with moderate to bright intensity both in interphase nuclei and on
metaphase chromosomes,Vysis LSI FOXO1 (Tel) SpectrumOrange
Probe(Vysis LSI FOXO1 (Tel) SpectrumOrange Probe)-The
SpectrumOrange Vysis LSI FOXO1 (Tel) fluorescence in situ
hybridization (FISH) probe is targeted to the 13q14 region on
chromosome 13. The probe is approximately 655kb in size and is
located telomeric of the FOXO1 gene. The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and metaphase chromosomes.,Vysis LSI FOXO1 (Cen)
SpectrumGreen Probe(Vysis LSI FOXO1 (Cen) SpectrumGreen
Probe)-The SpectrumGreen Vysis LSI FOXO1 (Cen) fluorescence in
situ hybridization (FISH) probe is targeted to the 13q14 region on
chromosome 13. The probe is approximately 724 kb in size and is
located centromeric of the FOXO1 gene. The hybridized probe
fluoresces with moderate to bright intensity both in interphase nuclei
and metaphase chromosomes.,Vysis LSI RUNX1/ RUNX1T1 Dual
Color Dual Fusion Probes(Vysis LSI RUNX1/ RUNX1T1 Dual Color
Dual Fusion Probes)-Vysis LSI RUNX1/RUNX1T1 Dual Color Dual
Fusion Probes hybridize to chromosome 8q21.3 (RUNX1T1 (ETO)
SpectrumOrange) and chromosome 21q22 (RUNX1 (AML1)
SpectrumGreen) . This probe is useful for the detection of the
translocation t(8;21)(q21.3;q22). The hybridized probe fluoresces with
moderate to bright intensity both in interphase nuclei and on

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metaphase chromosomes,Vysis LSI 21 SpectrumOrange Probe(Vysis
LSI 21 SpectrumOrange Probe)-Vysis LSI 21 SpectrumOrange DNA
probe hybridizes to the band region 21q22.13 - q22.2 (loci D21S259,
D21S341 and D21S342) of human chromosome 21. The hybridized
probe fluoresces with moderate to bright intensity both in interphase
nuclei and on metaphase chromosomes.,Vysis LSI 13 (RB1) 13q14
SpectrumOrange Probe(Vysis LSI 13 (RB1) 13q14 SpectrumOrange
Probe)-Vysis LSI 13 (RB1) 13q14 SpectrumOrange DNA probe
hybridizes to band 13q14 of human chromosome 13. The hybridized
probe fluoresces with bright intensity both in interphase nuclei and on
metaphase chromosomes.

625 IMP/IVD/2019/000444 Abbott Alinity m HCV CTRL Kit(Alinity m HCV CTRL Kit)-The Alinity m HCV CDSCO Class D
Healthcare Pvt. controls are for validity determination of the quantitative Alinity m HCV
Ltd. assay on the automated Alinity m System. These controls are
intended to be used with the Alinity m HCV assay,Alinity m HCV AMP
Kit(Alinity m HCV AMP Kit)-The Alinity m HCV assay is an in vitro
reverse transcription-polymerase chain reaction (RT-PCR) assay for
use with the automated Alinity m System to detect and quantitate
hepatitis C virus (HCV) RNA in human serum or plasma. The Alinity m
HCV assay is intended for use in the clinical management of HCV-
infected patients undergoing antiviral therapy in conjunction with
clinical presentation and other laboratory markers. The Alinity m HCV
assay may also be used as a diagnostic test to confirm active HCV
infection,Alinity m HCV CAL Kit(Alinity m HCV CAL Kit)-The Alinity m
HCV calibrators are for calibration for the Alinity m HCV assay on the
automated Alinity m System when used for the quantitative
determination of HCV RNA. The calibrators are intended to be used
with the Alinity m HCV assay

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626 IMP/IVD/2019/000445 Beckman Coulter Digoxin Calibrator(Digoxin Calibrator)-The Digoxin Calibrator is a CDSCO Class C
India Private liquid human serum based matrix calibrator intended to be used with
Limited Hisaria the Digoxin reagent OSR6404 for the quantitative determination of
Warehouse digoxin on Beckman Coulter analysers.,Digitoxin Calibrator(Digitoxin
Ground Floor Calibrator)-The Digitoxin Calibrator is a liquid human serum based
matrix calibrator intended to be used with the Digitoxin reagent
OSR6403 for the quantitative determination of digitoxin on Beckman
Coulter analysers.,Core TDM Multi-Calibrator(Core TDM Multi-
Calibrator)-The Core TDM Multi-Calibrator is intended to be used with
the reagents listed in the table below for the quantitative determination
of carbamazepine, phenobarbital, phenytoin, theophylline and valproic
acid on Beckman Coulter analysers.,VALPROIC ACID(VALPROIC
ACID)-Homogeneous enzyme immunoassay for the quantitative
determination of valproic acid in human serum and plasma on
Beckman Coulter
analysers,AMPHETAMINES/ECSTASY(AMPHETAMINES/ECSTASY)-
Homogeneous enzyme immunoassay for the qualitative and semi-
quantitative assay of amphetamines and ecstasy in human urine on
Beckman Coulter AU analysers.,OPIATES(OPIATES)-Homogeneous
enzyme immunoassay for the qualitative and semi-quantitative assay
of opiates in human urine on Beckman Coulter AU
analysers,METHADONE(METHADONE)-Homogeneous enzyme
immunoassay for the qualitative and semi-quantitative assay of
methadone in human urine on Beckman Coulter AU
analysers.,EDDP(EDDP)-Homogeneous enzyme immunoassay for
the qualitative and semi-quantitative assay of EDDP (2-ethylidine-1,5-
dimethyl-3,3-diphenylpyrrolidine) in human urine on Beckman Coulter
AU analysers,CARBAMAZEPINE(CARBAMAZEPINE)-Homogeneous
enzyme immunoassay for the quantitative determination of
carbamazepine in human serum and plasma on Beckman Coulter
analysers.,PHENOBARBITAL(PHENOBARBITAL)-Homogeneous
enzyme immunoassay for the quantitative determination of
phenobarbital in human serum and plasma on Beckman Coulter
analysers.,Antibiotic TDM Multi-Calibrator(Antibiotic TDM Multi-
Calibrator)-The Antibiotic TDM Multi-Calibrator is intended to be used
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with the Gentamycin reagent OSR6420 for the quantitative
determination of gentamycin on Beckman Coulter analysers.,DAU
THC 100 CALIBRATOR(DAU THC 100 CALIBRATOR)-The DAU THC
Calibrators are human urine based liquid calibrators intended to be
used with the THC reagent OSR6322 for the qualitative and semi-
quantitative determination of THC in human urine on Beckman Coulter
analysers.,DAU NEGATIVE CALIBRATOR(DAU NEGATIVE
CALIBRATOR)-The DAU Negative Calibrator is a human urine based
liquid calibrator intended to be used with DAU reagents listed in the
table below for the semi-quantitative determination of drugs of abuse
in human urine on Beckman Coulter
analysers.,BARBITURATES(BARBITURATES)-Homogeneous
enzyme immunoassay for the qualitative and semi-quantitative assay
of barbiturate in human urine on Beckman Coulter AU analysers. The
assay provides only a preliminary analytical test result. A more specific
alternative chemical method must be used to obtain a confirmed
analytical result. Gas chromatography/mass spectrometry (GC/MS) is
the preferred confirmatory method.1 Clinical consideration and
professional judgement should be applied to any drug of abuse test
result, particularly when using a preliminary positive
result.,BENZODIAZEPINES(BENZODIAZEPINES)-Homogeneous
enzyme immunoassay for the qualitative and semi-quantitative assay
of benzodiazepines in human urine on Beckman Coulter AU
analysers,COCAINE(COCAINE)-Homogeneous enzyme
immunoassay for the qualitative and semi-quantitative assay of the
cocaine metabolite benzoylecgonine in human urine on Beckman
Coulter AU analysers,DIGITOXIN(DIGITOXIN)-Immuno-inhibition test
for the quantitative determination of digitoxin in human serum on
Beckman Coulter analysers,PHENYTOIN(PHENYTOIN)-
Homogeneous enzyme immunoassay for the quantitative
determination of phenytoin in human serum and plasma on Beckman
Coulter analysers.,DIGOXIN(DIGOXIN)-Immuno-inhibition test for the
quantitative determination of digoxin in human serum on Beckman
Coulter analysers,GENTAMYCIN(GENTAMYCIN)-Homogeneous
enzyme immunoassay for the quantitative determination of

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gentamycin in human serum and plasma on Beckman Coulter
analysers,DAU METHADONE INTERMEDIATE CALIBRATOR(DAU
METHADONE INTERMEDIATE CALIBRATOR)-The DAU Methadone
Calibrators are human urine based liquid calibrators intended to be
used with the Methadone reagent OSR6319 for the qualitative and
semi-quantitative determination of methadone in human urine on
Beckman Coulter analysers.,DAU SECONDARY CUT-OFF MULTI-
DRUG CALIBRATOR(DAU SECONDARY CUT-OFF MULTI-DRUG
CALIBRATOR)-The DAU Multi-Drug Calibrators are human urine
based liquid calibrators intended to be used with DAU reagents listed
in the table below for the qualitative and semi-quantitative
determination of drugs of abuse in human urine on Beckman Coulter
analysers,DAU THC 50 CONTROL(DAU THC 50 CONTROL)-The
DAU THC Controls are human urine based liquid controls designed to
monitor the analytical preformance of the THC reagent OSR6322 on
Beckman Coulter analysers.,THC(THC)-Homogeneous enzyme
immunoassay for the qualitative and semi-quantitative assay of
cannabinoids (THC) in human urine on Beckman Coulter AU
analysers.,THEOPHYLLINE(THEOPHYLLINE)-Homogeneous
enzyme immunoassay for the quantitative determination of
theophylline in human serum and plasma on Beckman Coulter
analysers,DAU SPECIALITY CONTROL(DAU SPECIALITY
CONTROL)-The DAU Speciality Control is a human urine based liquid
control designed to monitor the analytical performance of the DAU
reagents on Beckman Coulter analysers.,DAU PRIMARY CUT-OFF
MULTI-DRUG CALIBRATOR(DAU PRIMARY CUT-OFF MULTI-DRUG
CALIBRATOR)-The DAU Multi-Drug Calibrators are human urine
based liquid calibrators intended to be used with DAU reagents for the
qualitative and semi-quantitative determination of drugs of abuse in
human urine on Beckman Coulter analysers,DAU HIGH MULTI-DRUG
CALIBRATOR(DAU HIGH MULTI-DRUG CALIBRATOR)-The DAU
Multi-Drug Calibrators are human urine based liquid calibrators
intended to be used with DAU reagents listed in the table below for
the qualitative and semi-quantitative determination of drugs of abuse
in human urine on Beckman Coulter analysers.,DAU METHADONE

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CUT-OFF CALIBRATOR(DAU METHADONE CUT-OFF
CALIBRATOR)-The DAU Methadone Calibrators are human urine
based liquid calibrators intended to be used with the Methadone
reagent OSR6319 for the qualitative and semi-quantitative
determination of methadone in human urine on Beckman Coulter
analysers.,DAU THC 75 CALIBRATOR(DAU THC 75 CALIBRATOR)-
The DAU THC Calibrators are human urine based liquid calibrators
intended to be used with the THC reagent OSR6322 for the qualitative
and semi-quantitative determination of THC in human urine on
Beckman Coulter analysers.,DAU INTERMEDIATE MULTI-DRUG
CALIBRATOR(DAU INTERMEDIATE MULTI-DRUG CALIBRATOR)-
The DAU Multi-Drug Calibrators are human urine based liquid
calibrators intended to be used with DAU reagents listed in the table
below for the qualitative and semi-quantitative determination of drugs
of abuse in human urine on Beckman Coulter analysers.,DAU THC 25
CALIBRATOR(DAU THC 25 CALIBRATOR)-The DAU THC
Calibrators are human urine based liquid calibrators intended to be
used with the THC reagent OSR6322 for the qualitative and semi-
quantitative determination of THC in human urine on Beckman Coulter
analysers,DAU THC 50 CALIBRATOR(DAU THC 50 CALIBRATOR)-
The DAU THC Calibrators are human urine based liquid calibrators
intended to be used with the THC reagent OSR6322 for the qualitative
and semi-quantitative determination of THC in human urine on
Beckman Coulter analysers.,DAU THC 25 CONTROLS(DAU THC 25
CONTROLS)-The DAU THC Controls are human urine based liquid
controls designed to monitor the analytical preformance of the THC
reagent OSR6322 on Beckman Coulter analysers.,DAU
METHADONE HIGH CALIBRATOR(DAU METHADONE HIGH
CALIBRATOR)-The DAU Methadone Calibrators are human urine
based liquid calibrators intended to be used with the Methadone
reagent OSR6319 for the qualitative and semi-quantitative
determination of methadone in human urine on Beckman Coulter
analysers.,DAU MULTI-DRUG CONTROL(DAU MULTI-DRUG
CONTROL)-The DAU Multi-Drug Control is a human urine based

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liquid control designed to monitor the analytical performance of the
DAU reagents listed in the table below on Beckman Coulter analysers.

627 IMP/IVD/2019/000448 Abbott Alere™ h380(Alere™ h380)-This hematology analyzer is a fully CDSCO Class A
Diagnostics automated cell counter designed for in vitro diagnostic use, developed
Medical Private for small clinics.,Alere™ H560(Alere™ H560)-The ‘Alere H 560’ is a
Limited fully automated high quality hematology analyzer for in vitro diagnostic
use in clinical laboratories. It provides precise and accurate 5-part
differential measurement using a laser based optical measurement
technology.

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628 IMP/IVD/2019/000448 Abbott H 380 Hemo Control Kit(H 380 Hemo Control Kit)-H 380 Hemo CDSCO Class B
Diagnostics Control Kit is a control designed to monitor values on automated and
Medical Private semi-automated impedance type hematology analyzers. It can also be
Limited used for manual methods. Please refer to the assay table for specific
instrument models.,H 380 Hemo Control High(H 380 Hemo Control
High)-H 380 Hemo Control High is a control designed to monitor
values on automated and semi-automated impedance type
hematology analyzers,H 380 Hemo Control Normal(H 380 Hemo
Control Normal)-H 380 Hemo Control Normal is a control designed to
monitor values on automated and semi-automated impedance type
hematology analyzers,H 560 Hemo Control Kit(H 560 Hemo Control
Kit)-H 560 Hemo Control Kit is an assayed whole blood control
designed to monitor values on multi parameter hematology cell
counters.,H 560 Hemo Control High(H 560 Hemo Control High)-H 560
Hemo Control High is an assayed whole blood control designed to
monitor values on multi parameter hematology cell counters,H 560
Hemo Control Normal(H 560 Hemo Control Normal)-H 560 Hemo
Control Normal is an assayed whole blood control designed to monitor
values on multi parameter hematology cell counters,H 560 Hemo
Control Low(H 560 Hemo Control Low)-H 560 Hemo Control Low is
an assayed whole blood control designed to monitor values on multi
parameter hematology cell counters. Please refer to the assay table
for specific instrument models.,H 380 Hemo Control LOW(H 380
Hemo Control LOW)-H 380 Hemo Control Low is a control designed
to monitor values on automated and semi-automated impedance type
hematology analyzers,H 560 Dil 5 P(H 560 Diff 5 P)-H 560 Dil 5 P
diluent is a buffered, stabilized and microfiltered electrolyte solution for
automated dilution of human blood samples, quantitative and
qualitative determination of erythrocytes (RBC), leukocytes (WBC)
and the leukocyte subpopulations, thrombocytes (PLT) and
measurement of hemoglobin (HGB) concentration on H 560
hematology analyzers.,H 3P Reagent Smart Pack(H 3P Reagent
Smart Pack)-H 3P Reagent Smart Pack WBC-3-diff reagent set is a
reagent set for counting of erythtrocytes (RBC), platelets (PLT), for
haemoglobin (HGB) measurement, and for quantitative determination
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of leukocytes (WBC), leukocyte 3-part differentiation (LYM, MID, GRA)
in human blood on Aquila/ A60 hematology analyzers.,H 380 Dil 3P(H
380 Dil 3P)-H 380 Dil 3P diluent is a buffered, stabilized and
microfiltered electrolyte solution for automated dilution of human blood
samples, quantitative and qualitative determination of erythrocytes
(RBC), leukocytes (WBC) and the leukocyte subpopulations,
thrombocytes (PLT) and measurement of hemoglobin (HGB)
concentration on H 380 hematology analyzers.,H Hemo Calibrator(H
Hemo Calibrator)-H Hemo Calibrator is designed for use in the
calibration of hematology analyzers,H Hypoclean(H Hypoclean)-H
Hypoclean hypochlorite cleaning concentrate is a stabilized and
micro-filtered hypochlorite solution for intensive oxidative cleaning,
rinsing and washing of hematology analyzers’ capillaries, tubing and
chambers, removing blood component precipitates and lipoprotein
deposits on H 560 / H 380 hematology analyzers.,H 560 Lyse 5 P(H
560 Lyse 5 P)-H 560 Lyse 5 Plysing reagent is a stabilized and
microfiltered lysing agent for stromatolysis of erythtrocytes (RBC), for
quantitative determination of leukocytes (WBC), leukocyte 5-part
differentiation (LYM, MONO, NEU, EO, BA) and hemoglobin (HGB)
concentration measurement in human blood on H 560 hematology
analyzers,H 380 Cleaner(H 380 Cleaner)-H 380 Cleaner cleaning
reagent is a stabilized and micro- filtered detergent solution for regular
automated cleaning, rinsing and washing of hematology analyzers’
capillaries, tubing and chambers, removing blood component
precipitates and lipoprotein deposits on H 380 hematology
analyzers.,H 380 Lyse Diff 3 P(H 380 Lyse Diff 3 P)-H 380 Lyse Diff 3
P lysing reagent is a stabilized and micro- filtered lysing agent for
stromatolysis of erythtrocytes (RBC), for quantitative determination of
leukocytes (WBC), leukocyte three-part differentiation (LYM, MID,
GRAN) and hemoglobin (HGB) concentration measurement in human
blood on H 380 hematology analyzers.,H 560 Diff 5 P(H 560 Diff 5 P)-
H 560 Diff 5 P lysing reagent is a stabilized and micro-filtered reagent
for quantitative determination of leukocytes (WBC) and leukocyte 5-
part differentiation (LYM, MONO, NEU, EO, BA) measurement in
human blood on H 560 hematology analyzers

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

629 IMP/IVD/2019/000449 Ragok Medicare One Step Propoxyphene Urine Test(Wondfo)-Qualitative detection of CDSCO Class C
Private Limited Propoxyphene and its principal metabolites in human urine at
specified cut-off level,One step Morphine Urine Test(Wondfo)-
Qualitative detection of Morphine and its principal metabolites in
human urine at specified cut-off level,One Step Marijuana Urine
Test(Wondfo)-Qualitative detection of Marijuana and its principal
metabolites in human urine at specified cut-off level ,One step
Oxycodone Urine Test(Wondfo)-Qualitative detection of Oxycodone
and its principal metabolites in human urine at specified cut-off
level,One Step Opiate Urine Test(Wondfo)-Qualitative detection of
Opiate and its principal metabolites in human urine at specified cut-off
level (300 ng/ml, 2000 ng/ml),One Step Cotinine Urine Test(Wondfo)-
Qualitative detection of Cotinine and its principal metabolites in human
urine at specified cut-off level,One Step Multi Drug Urine Test
Panel(Wondfo)-Wondfo One Step Multi-Drug Urine Test Panel is
consisted of individual one-step immunoassays. The test is a lateral
flow, one-step immunoassay for the qualitative detection of specific
drugs and their metabolites in human urine,One Step Multi-Drug Urine
T-Cup (+ Adulteration and Temperature control)(Wondfo)-Wondfo One
Step Multi-Drug Urine T-Cup is rapid urine screening test. The test is a
lateral flow, one-step immunoassay for the qualitative detection of
specific drugs and their metabolites in human urine,One Step
Tramadol Urine Test(Wondfo)-The Wondfo One Step Tramadol Urine
Test is a lateral flow chromatographic immunoassay for the detection
of Tramadol in human urine at the cut-off concentration of 1000
ng/ml.,One Step Barbiturates Urine Test(Wondfo)-Qualitative detection
of Barbiturates and its principal metabolites in human urine at
specified cut-off level.,One Step Benzodiazepines Urine
Test(Wondfo)-Qualitative detection of Benzodiazepines and its
principal metabolites in human urine at specified cut-off level,One
Step Cocaine Urine Test(Wondfo)-Qualitative detection of Cocaine
and its principal metabolites in human urine at specified cut-off
level,One step Methamphetamine Urine Test(Wondfo)-Qualitative
detection of Methamphetamine and its principal metabolites in human
urine at specified cut-off level,One Step Buprenorphine Urine
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Test(Wondfo)-Qualitative detection of Buprenorphine and its principal
metabolites in human urine at specified cut-off level,One step
Amphetamine Urine Test(Wondfo)-Qualitative detection of
Amphetamine and its principal metabolites in human urine at specified
cut-off level.

630 IMP/IVD/2019/000450 BioMerieux India HOKAPI AE-180(HOKAPI)-HOKAPI AE 180 used in with specilized CDSCO Class A
Pvt. Ltd. chemiluminescence immune analysis reagent box on the basis of
chemiluminescence immune analysis technology and can be used in
quantitative and qualitative analysis of related substances in human
body samples

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631 IMP/IVD/2019/000450 BioMerieux India Pregnancy Associated Plasma Protein A Assay Kit-For the quantitative CDSCO Class B
Pvt. Ltd. in vitro diagnostic determination of Pregnancy Associated Plasma
Protein A in human serum.,IgG Antibody to Hepatitis E Virus Assay
Kit-For qualitative measurement of IgG antibodies to hepatitis E virus
in human serum (plasma).,Progesterone Assay Kit -Immunoassay for
the in vitro quantitative determination of Progesterone（P）in human
serum.,Estradiol Assay Kit-Immunoassay for the in-vitro quantitative
determination of Estradiol (E2) in human serum.,Parathyroid Hormone
Assay Kit-For the quantitative in vitro diagnostic determination of
Parathyroid Hormone in human serum,IgM Antibody to Hepatitis E
Virus Assay Kit-For qualitative measurement of IgM antibodies to
hepatitis E virus in human serum (plasma).,Human Chorionic
Gonadotrophin B-Subunit Assay Kit-Immunoassay for the in vitro
quantitative determination of Chorionic Gonadotropin β-Subunit（β-
HCG）in human serum.,Ferritin Assay Kit-Immunoassay for the in
vitro quantitative determination of Ferritin (Fer) in human serum.,25-
OH Vitamin D Assay Kit-Immunoassay for the in vitro quantitative
determination of 25-OH Vitamin D（25-OH VD）in human
serum.,Prolactin Assay Kit-Immunoassay for the in vitro quantitative
determination of prolactin (PRL) in human serum.,Testosterone Assay
Kit-Immunoassay for the in vitro quantitative determination of
Testosterone (T) in human serum.,Luteinizing Hormone Assay Kit-
Immunoassay for the in vitro quantitative determination of luteinizing
hormone (LH) in human serum.,Follicle Stimulating Hormone Assay
Kit-Immunoassay for the in vitro quantitative determination of follicle
stimulating hormone（FSH）in human serum.,Human Chorionic
Gonadotropin Assay Kit-Immunoassay for the in vitro quantitative
determination of human chorionic gonadotropin (HCG) in human
serum.,Thyroglobulin Assay Kit-Immunoassay for the in vitro
quantitative determination of thyroglobulin (TG) in human
serum.,Antibody to Thyroglobulin (Anti-TG) Assay Kit-Immunoassay
for the in vitro quantitative detection of antibody to thyroglobulin (Anti-
TG) in human serum.,Triiodothyronine Assay Kit-Immunoassay for the
in vitro quantitative detection of the total triiodothyronine (T3) in
human serum.,Thyroxine Assay Kit-Immunoassay for the in vitro
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quantitative detection of total thyroxine (T4) in human serum.,Antibody
to Thyroid Peroxidase Assay Kit-Immunoassay for the in vitro
quantitative detection of antibody to thyroid peroxidase (Anti-TPO) in
human serum.,Free Triiodothyronine Assay Kit-Immunoassay for the
in vitro quantitative detection of free Triiodothyronine (FT3) in human
serum.,Thyroid Stimulating Hormone Assay Kit-Immunoassay for the
in vitro quantitative determination of thyroid stimulating hormone
(TSH) in human serum.,Free Thyroxine Assay Kit-Immunoassay for
the in vitro quantitative detection of free thyroxine (FT4) in human
serum.,Procollagen III N-terminal Peptide Assay Kit-For the in vitro
quantitative determination of procollagen Ⅲ N-terminal peptide（PⅢ
NP）in human serum.,Collagen Type IV Assay Kit-For the in vitro
quantitative determination of collagen type IV (CⅣ) in human
serum,Cholylglycine Assay Kit-For quantative measurement of
cholylglycine in human serum.,C-Peptide Assay Kit-For the in vitro
quantitative determination of C- peptide (C-P) in human serum.,N
terminal peptide Bone gamma-carboxyglutamic acid-containing
proteins assay Kit-For the quantitative in vitro diagnostic determination
of N-BGP in human serum,Anti-Myeloperoxidase Assay Kit-For the
quantitative in vitro diagnostic determination of anti-myeloperoxidase
antibodies in human serum,Hyaluronic Acid Assay Kit-For the in vitro
quantitative determination of hyaluronic acid（HA）in human
serum,Insulin Assay Kit-For the in vitro quantitative determination of
insulin (INS) in human serum.,Anti-proteinase 3 Assay Kit-For the
quantitative in vitro diagnostic determination of anti-PR3 in human
serum.,Laminin Assay Kit-For the in vitro quantitative determination of
laminin（LN） in human serum,Anti-cyclic Citrullinated Peptide
Antibody Assay Kit-For the quantitative in vitro diagnostic
determination of calcitonin in human serum.,Anti-doublestranded
Deoxyribonucleic acid antibody Assay Kit-For the quantitative in vitro
diagnostic determination of Anti-doublestranded Deoxyribonucleic acid
antibody (Anti-dsDNA) in human serum.,Substrate Solution-This
reagent is designed to work together with many other reagents (such
as primary antibody, secondary antibody, standard substance, and
stopping solution e.g.), so as to complete in vitro test based on

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immunity principle.,The MB Isoenzyme of Creatine Kinase Assay Kit-
For in-vitro quantitative determination of the MB Isoenzyme of
Creatine Kinase (CK-MB) in human serum,Sample Diluent-Used for
the diluting or liquefying of specimen to be detected, so that the
specimen could be measured by on the equipment.,Cleaning Solution-
For the cleaning of reaction system during the inspection process, so
as to perform in vitro test on the substance being tested.

632 IMP/IVD/2019/000452 RAPHA URINE ANALYZER HC-300(DIRUI)-TO BE USED FOR THE CDSCO Class A
DIAGNOSTICS QUALITATIVE AND QUANTITATIVE IN-VITRO DETERMINATION OF
PVT. LTD. VARIOUS CHEMICAL AND CELLULAR CONSTITUENTS OF A
CLINICAL URINE SPECIMEN.,URINE ANALYZER H-100(DIRUI)-TO
BE USED FOR THE QUALITATIVE AND QUANTITATIVE IN-VITRO
DETERMINATION OF VARIOUS CHEMICAL AND CELLULAR
CONSTITUENTS OF A CLINICAL URINE SPECIMEN. ,URINE
ANALYZER H-500(DIRUI)-TO BE USED FOR THE QUALITATIVE
AND QUANTITATIVE IN-VITRO DETERMINATION OF VARIOUS
CHEMICAL AND CELLULAR CONSTITUENTS OF A CLINICAL
URINE SPECIMEN.

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633 IMP/IVD/2019/000452 RAPHA Reagent Strips for Urinalysis(DIRUI H11-MA)-DIRUI H11-MA Reagent CDSCO Class B
DIAGNOSTICS Strips for Urinalysis are made for urinalysis of both qualitative and
PVT. LTD. semi-quantitative, which are in vitro reagent for diagnostics. It is used
for qualitative and semi-quantitative test of urobilinogen, bilirubin,
ketone, blood, protein, nitrite, leucocytes, glucose, specific gravity, pH
& microalbumin in urine. The strips are for professional use only.
DIRUI H11-MA Reagent strips for urinalysis can be read visually and
instrumentally using H-50, H-100, H-300 & H-500 Urine Analyzers,
which is also manufactured by M/s. DIRUI Industrial Co. Ltd.,Reagent
Strips for Urinalysis(DIRUI 2 ITEMS (GLU, KET))-DIRUI 2 ITEMS
(GLU, KET) Reagent Strips for Urinalysis are made for urinalysis of
both qualitative and semi-quantitative, which are in vitro reagent for
diagnostics. It is used for qualitative and semi-quantitative test of
Glucose & Ketone in urine. The strips are for professional use
only.,Reagent Strips for Urinalysis (DIRUI H10)-DIRUI H10 Reagent
Strips for Urinalysis are made for urinalysis of both qualitative and
semi-quantitative, which are in vitro reagent for diagnostics. It is used
for qualitative and semi-quantitative test of urobilinogen, bilirubin,
ketone, blood, protein, nitrite, leucocytes, glucose, specific gravity and
pH in urine. The strips are for professional use only. DIRUI H10
Reagent strips for urinalysis can be read visually and instrumentally
using H-50, H-100, H-300 & H-500 Urine Analyzers, which is also
manufactured by M/s. DIRUI Industrial Co. Ltd. ,Reagent Strips for
Urinalysis (DIRUI A10)-DIRUI A10 Reagent Strips for Urinalysis are
made for urinalysis of both qualitative and semi-quantitative, which are
in vitro reagent for diagnostics. It is used for qualitative and semi-
quantitative test of urobilinogen, bilirubin, ketone, blood, protein,
nitrite, leucocytes, glucose, specific gravity and pH in urine. The strips
are for professional use only. ,Reagent Strips for Urinalysis (DIRUI 8
ITEMS)-DIRUI 8 ITEMS Reagent Strips for Urinalysis are made for
urinalysis of both qualitative and semi-quantitative, which are in vitro
reagent for diagnostics. It is used for qualitative and semi-quantitative
test of urobilinogen, protein, pH , blood, specific gravity, ketone,
bilrubin & glucose in urine. The strips are for professional use only.
,Reagent Strips for Urinalysis (DIRUI 1 ITEM (GLU))-DIRUI 1 ITEM
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(GLU) Reagent Strips for Urinalysis are made for urinalysis of both
qualitative and semi-quantitative, which are in vitro reagent for
diagnostics. It is used for qualitative and semi-quantitative test of
glucose in urine. The strips are for professional use only. ,Reagent
Strips for Urinalysis (DIRUI 5 ITEMS)-DIRUI 5 ITEMS Reagent Strips
for Urinalysis are made for urinalysis of both qualitative and semi-
quantitative, which are in vitro reagent for diagnostics. It is used for
qualitative and semi-quantitative test of glucose, pH , protein, ketone
and blood in urine. The strips are for professional use only.,Reagent
Strips for Urinalysis (DIRUI 4 ITEMS)-DIRUI 4 ITEMS Reagent Strips
for Urinalysis are made for urinalysis of both qualitative and semi-
quantitative, which are in vitro reagent for diagnostics. It is used for
qualitative and semi-quantitative test of glucose, pH , specific gravity
and protein in urine. The strips are for professional use only. ,Reagent
Strips for Urinalysis (DIRUI 2 ITEMS (PRO, GLU))-DIRUI 2 ITEMS
(PRO, GLU) Reagent Strips for Urinalysis are made for urinalysis of
both qualitative and semi-quantitative, which are in vitro reagent for
diagnostics. It is used for qualitative and semi-quantitative test of
glucose & protein in urine. The strips are for professional use only.

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634 IMP/IVD/2019/000453 Instrumentation HemosIL HIT-Ab (PF4-H)(HemosIL)- Fully auotomated latex CDSCO Class C
Laboratory India enhanced immunoassay for the semi-quantitative detection of total
Pvt Ltd immunoglobulin in human citrated plasma that reacts with Platlet
factor 4(PF4) when complexed with to heparin on the ACL TOP
Family. Heparin Associated antibodies are commonly found in patients
with heparin induced thrombocytopenia or thrombosis (HIT).,HemosIL
Acustar - Von Willebrand Factor Collagen Binding Activity(HemosIL)-
The HemosIL AcuStar von Willebrand FactorCollagen Binding Activity
assay (HemosIL AcuStar VWF : CB) is a fully automated
chemiluminescent immunoassay for the quantitative determination of
von Willebrand Factor Collagen Binding Activity in human citrated
plasma on the ACL AcuStar. The HemosIL AcuStar VWF:CB assay is
indicated for use on patients who are suspected of having von
Willebrand Disease (VWD).,HemosIL FDP(HemosIL)-Automated latex
enhanced immunoassay for the quantitative determination of
fibrin(ogen) degradation products (FDP) in human citrated plasma on
ACL TOP® Family Systems.

635 IMP/IVD/2019/000454 Beckman Coulter iQ Body Fluids Controls - Level I and Level II(iQ Body Fluids Controls CDSCO Class B
India Private - Level I and Level II)-iQ Body Fluids Controls are intended for use on
Limited iQ Series Analyzers, with the optional iQ Body Fluids Module installed,
as a control for evaluating body fluid RBC and nucleated cell counts.
The kit includes two levels of red blood cells and nucleated cells. For
in vitro diagnostic use.

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636 IMP/IVD/2019/000454 Beckman Coulter ClearLLab Control Cells Normal(ClearLLab Control Cells Normal)- CDSCO Class C
India Private ClearLLab Control Cells Normal and ClearLLab Control Cells
Limited Abnormal are stabilized preparations of assayed, lysable whole blood
intended as process controls for the verification of the ClearLLab 10C
Panels on the Navios and Navios EX flow cytometers. Parameters
assayed include: Kappa, Lambda, CD5, CD200, CD38, CD20, CD19,
CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8, CD16, CD10,
CD13, CD64, CD14, HLA-DR, CD11b, CD15, CD33, CD34, CD117,
and CD123. They provide positive cell controls that are processed in
the same manner as a whole blood sample. This allows verification of
reagent performance and the methods used for staining targeted cells,
lysing erythrocytes, and analyzing samples with flow
cytometry,ClearLLab Control Cells Abnormal(ClearLLab Control Cells
Abnormal)-ClearLLab Control Cells Normal and ClearLLab Control
Cells Abnormal are stabilized preparations of assayed, lysable whole
blood intended as process controls for the verification of the
ClearLLab 10C Panels on the Navios and Navios EX flow cytometers.
Parameters assayed include: Kappa, Lambda, CD5, CD200, CD38,
CD20, CD19, CD45, TCRγδ, CD4, CD2, CD56, CD3, CD7, CD8,
CD16, CD10, CD13, CD64, CD14, HLA-DR, CD11b, CD15, CD33,
CD34, CD117, and CD123. They provide positive cell controls that are
processed in the same manner as a whole blood sample. This allows
verification of reagent performance and the methods used for staining
targeted cells, lysing erythrocytes, and analyzing samples with flow
cytometry

637 IMP/IVD/2019/000457 Immucor India HLA Antibody Kit (LSA Class II)(Lifecodes LSA Class II)-LIFECODES CDSCO Class C
Pvt. Ltd., LSA™ Class I and Class II are bead-based immunoassays used to
qualitatively detect HLA IgG antibodies.,HLA Antibody Kit (LSA Class
I)(Lifecodes LSA Class I)-LIFECODES LSA™ Class I and Class II are
bead-based immunoassays used to qualitatively detect HLA IgG
antibodies.

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638 IMP/IVD/2019/000457 Immucor India SSO Typing Kit(Immucor Lifecodes HLA-A eRES SOO Typing Kit)- CDSCO Class D
Pvt. Ltd., DNA Typing of Class I and Class II HLA Allies, to aid in transfusion
and transplantation donor and recipient matching.,SSO Typing
Kit(Immucor Lifecodes HLA-B eRES SSO Typing Kit)-DNA Typing of
Class I and Class II HLA Allies, to aid in transfusion and
transplantation donor and recipient matching.,SSO Typing
Kit(Immucor Lifecodes HLA-DRB1 eRES SSO Typing Kit)-DNA Typing
of Class I and Class II HLA Allies, to aid in transfusion and
transplantation donor and recipient matching.,Antibody
Kit(LIFECODES LifeScreen Deluxe)-LIFECODES LifeScreen Deluxe
is a qualitative bead-based immunoassay used to detect IgG
antibodies to HLA Class I and Class II molecules.,Antibody
Kit(LIFECODES Class I ID)-LIFECODES Class I ID is a bead-based
immunoassay used to qualitatively detect Panel Reactive HLA IgG
antibodies (PRA).,SSO Typing Kit [628915](Immucor)-DNA Typing of
Class I and Class II HLA Allies, to aid in transfusion and
transplantation donor and recipient matching.,Antibody
Kit(LIFECODES Class II IDv2)-LIFECODES Class II IDv2 is a bead-
based immunoassay used to qualitatively detect Panel Reactive HLA
IgG antibodies (PRA).,SSO Typing Kit [628930](Immucor)-DNA Typing
of Class I and Class II HLA Allies, to aid in transfusion and
transplantation donor and recipient matching.,SSO Typing Kit [628911]
(Immucor)-DNA Typing of Class I and Class II HLA Allies, to aid in
transfusion and transplantation donor and recipient matching.,SSO
Typing Kit [628511](Immucor)-DNA Typing of Class I and Class II HLA
Allies, to aid in transfusion and transplantation donor and recipient
matching.,SSO Typing Kit [628075](Immucor)-DNA Typing of Class I
and Class II HLA Allies, to aid in transfusion and transplantation donor
and recipient matching.,SSO Typing Kit [628927](Immucor)-DNA
Typing of Class I and Class II HLA Allies, to aid in transfusion and
transplantation donor and recipient matching.,SSO Typing Kit
[628923](Immucor)-DNA Typing of Class I and Class II HLA Allies, to
aid in transfusion and transplantation donor and recipient
matching.,SSO Typing Kit [628921(Immucor)-DNA Typing of Class I
and Class II HLA Allies, to aid in transfusion and transplantation donor
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and recipient matching.,LIFECODES HLA-DPA1/B1 SSO TYPING
KIT(Immucor LIFECODES HLA-DPA1/B1 SSO TYPING KIT)-DNA
Typing of Class I and Class II HLA alleles, to aid in transfusion and
transplantation donor and recipient matching.

639 IMP/IVD/2019/000458 Abbott Pima CD4 (Cartridge)(Pima CD4 (Cartridge))-Pima CD4 is an CDSCO Class C
Diagnostics automated, image-based, immune haematology test intended for the
Medical Private rapid in vitro quantitative measurement of CDg+/CD++ T cells (T-
Limited helper cells) in capillary or venous whole blood

640 IMP/IVD/2019/000459 Roche CleanCell M(CleanCell M)-System solution for cleaning the detection CDSCO Class A
Diagnostics India unit of Elecsys or cobas e immunoassay analyzers.,NACL(NACL)-
Pvt. Ltd. Diluent NaCl 9 % is used as a sample diluent in conjunction with
assay reagents.,SMS(SMS)-Wash solution for reagent probes and
reaction cells.,ECO-D(ECO-D)-EcoTergent is an additive to the
reaction bath to reduce surface tension.,NAOHD(NAOHD)-Wash
solution for reagent probes and reaction cells.,Cell Wash Solution
I/NaOH-D(Cell Wash Solution I/NaOH-D)-Cell Wash Solution I /
NaOH‑D is used as alkaline wash solution for reaction cells on
Roche/Hitachi systems.

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641 IMP/IVD/2019/000459 Roche Elecsys Prolactin II(Elecsys Prolactin II)-Immunoassay for the in vitro CDSCO Class B
Diagnostics India quantitative determination of prolactin in human serum and plasma.
Pvt. Ltd. The electrochemiluminescence immunoassay “ECLIA” is intended for
use on Elecsys and cobas e immunoassay analyzers.
,HBDH2(HBDH2)-In vitro test for the quantitative determination of
α‑hydroxybutyrate dehydrogenase (α‑HBDH) in serum and
plasma.,AMYL2(AMYL2)-In vitro test for the quantitative determination
of α‑amylase in human serum, plasma and urine.,LDHI2(LDHI2)-In
vitro test for the quantitative determination of lactate dehydrogenase
in human serum and plasma.,MG2(MG2)-In vitro test for the
quantitative determination of magnesium in human serum, plasma
and urine.,ALP2(ALP2)-In vitro test for the quantitative determination
of alkaline phosphatase in human serum and plasma.,CHE2(CHE2)-In
vitro test for the quantitative determination of cholinesterase in human
serum and plasma.,GGT-2(GGT-2)-n vitro test for the quantitative
determination of γ‑glutamyltransferase (GGT) in human serum and
plasma.,SI2(SI2)-In vitro test for the semi-quantitative determination of
the lipemia index, hemolysis index and icterus index in human serum
and plasma.,IRON2(IRON2)-In vitro test for the quantitative
determination of iron in human serum and plasma.,HDLC4(HDLC4)-In
vitro diagnostic test for the quantitative determination of the
HDL‑cholesterol concentration in human serum and
plasma.,PHOS2(PHOS2)-In vitro test for the quantitative
determination of phosphorus in human serum, plasma and
urine.,PREA(PREA)-In vitro test for the quantitative determination of
prealbumin in human serum and plasma.,LDLC3(LDLC3)-In vitro test
for the quantitative determination of LDL-cholesterol in human serum
and plasma.,CREJ2(CREJ2)-In vitro test for the quantitative
determination of creatinine in human serum, plasma and
urine.,APOAT(APOAT)-In vitro test for the quantitative determination
of Apolipoprotein A‑1 in human serum and plasma.,APOBT(APOBT)-
In vitro test for the quantitative determination of apolipoprotein B in
human serum and plasma.,CO2-L(CO2-L)-In vitro test for the
quantitative determination of bicarbonate (HCO3-) in human serum
and plasma.,CK(CK)-In vitro test for the quantitative determination of
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creatine kinase (CK) in human serum and plasma.,BILD2(BILD2)-In
vitro test for the quantitative determination of direct bilirubin in serum
and plasma.,CA2(CA2)-In vitro test for the quantitative determination
of calcium in human serum, plasma and urine.,CHOL2(CHOL2)-In
vitro test for the quantitative determination of cholesterol in human
serum and plasma on Roche/Hitachi cobas c systems.,UA2(UA2)-In
vitro test for the quantitative determination of uric acid in human
serum, plasma and urine on Roche/Hitachi cobas c systems.
,GLUC3(GLUC3)-In vitro test for the quantitative determination of
glucose in human serum, plasma, urine and CSF on Roche/Hitachi
cobas c systems. ,TRIGL(TRIGL)-In vitro test for the quantitative
determination of triglycerides in human serum and plasma on
Roche/Hitachi cobas c systems. ,UREAL(UREAL)-In vitro test for the
quantitative determination of urea/urea nitrogen in human serum,
plasma and urine on Roche/Hitachi cobas c systems.,TRSF2(TRSF2)-
In vitro test for the quantitative determination of transferrin in human
serum and plasma on Roche/Hitachi cobas c systems. ,FRA(FRA)-In
vitro test for the quantitative determination of glycated proteins
(fructosamine) in human serum and plasma on Roche/Hitachi cobas c
systems. ,TP2(TP2)-In vitro test for the quantitative determination of
total protein in human serum and plasma on Roche/Hitachi cobas c
systems.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

642 IMP/IVD/2019/000460 PAMED Anti TG Elisa(Diametra)-Indirect Immunoenzymatic colorimetric CDSCO Class B

SERVICES PVT. method for quantitative determination of Anti-TG concentration in
LTD. human serum or plasma. Anti TG Elisa Kit is intended for laboratory
use only.,Testosterone Elisa(Diametra)-Competitive Immune
enzymatic colorimetric method for quantitive determination of total
Testosterone concentration in human serum or plasma. Testosterone
Elisa kit is intended for laboratory use only,Cortisol elisa(Diametra)-
Competitive Immunoenzymatic colorimetric method for quantitative
determination of Cortizol concentration in human serum or plasma.
Cortizol Elisa Kit is intended for laboratory use only.,DHEA-S
Elisa(Diametra)-Competitive Immunoenzymatic colorimetric method of
quantitative determination of Dehydro-epiandrosterone sulfate (DHEA-
S) concentration in human serum or plasma. DHEA-S Elisa Kit is
intended for laboratory use only,17 OH Progesterone Elisa(Diametra)-
Competitive Immunoenzymatic colorimetric method of quantitative
determination of 17OH Progesterone concentration in human serum
or plasma. 17OH Progesterone Elisa Kit is intended for laboratory use
only,Estradiol Elisa(Diametra)-Competitive Immunoenzymatic
colorimetric method for quantitative determination of 17-b-Estradiol
concentration in human serum or plasma. Estradiol kit is intended for
laboratory use only.,DHEA-S saliva elisa(Diametra)-Competitive
Immunoenzymatic colorimetric method for quantitative determination
of DHEA-S concentration in saliva. DHEA-S saliva Elisa Kit is
intended for laboratory use only.,Cortisol Saliva Elisa(Diametra)-
Competitive Immunoenzymatic colorimetric method for quantitative
determination of Cortisol concentration in saliva. Cortisol Saliva Elisa
Kit intended for laboratory use only.,Total Estriol Elisa(Diametra)-
Competitive Immunoenzymatic colorimetric method for quantitative
determination of Total Estriol concentration in human serum or
plasma. Total Estriol Elisa Kit intended for laboratory use only.,Insulin
Elisa(Diametra)-Direct solid phase enzyme Immunoasssay for
quantitative determination of Insulin in human serum or plasma.
insulin Elisa Kit is intended for laboratory use only.,Aldosterone
Elisa(Diametra)-Competitive Immunoenzymatic colorimetric method
for quantitative determination of Aldosterone concentration in human
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serum plasma or urine. Aldosterone Elisa Kit is intended for laboratory
use only.,T4 Elisa(Diametra)-Immunoenzymatic colorimetric method
for quantitative determination of Throxine (T4) concentration in human
serum and plasma. T4 Elisa Kit is intended for laboratory use
only.,Free Testosterone Elisa(Diametra)-Competitive
Immunoenzymatic colorimetric method for quantitative determination
of Free Testosterone concentration in human serum or plasma.
Second Generation kit free Testosterone Elisa Kit intended for
laboratory use only.,Prolactin Elia(Diametra)-Immunoenzymatic
colorimetric method for quantitative determination of Prolactin
concentration in human serum or plasma. Porlactin Elisa Kit intended
for laboratory use only.,Androstendione Elisa(Diametra)-Competitive
Immunoenzymatic colorimetric method for quantitative determination
of Androstenedione concentration in human serum or plasma.
Androstenedione Elisa Kit intended for laboratory use only.,T3
Elisa(Diametra)-Immunoenzymatic colorimetric method for
quantitative determination of Triiodothyronine (T3) concentration in
human serum and plasma. T3 Elisa Kit is intended for laboratory use
only.,TSH Elisa(Diametra)-Immunoenzymatic colorimetric method for
quantitative determination of thyroid-stimulating hormone (TSH,
throtropin) concentration in human serum or plasma. TSH Elisa Kit
intended for laboratory use only.,Progesterone Elisa(Diametra)-
Competitive Immunoenzymatic colorimetric method for quantitative
determination of Progesterone concentration in human serum or
plasma. Progesterone Elisa Kit intended for laboratory use only.,Free
Estriol Elisa(Diametra)-Competitive Immunoenzymatic colorimetric
method for quantitative determination of free Estriol concentration in
human serum or plasma. Free Estriol Elisa Kit is intended for
laboratory use only.,25OH Vitamin D(Diametra)-Immunoenzymatic
colorimetric method for quantitative determination of 25OH Vitamin D
concentration in human serum or plasma. 25 OH Vitamin D Kit is
intended for laboratory use only.,Anti Phospholipid Screen(Diametra)-
Anti Phospholipid screen is an indirect solid phase immunoassay kit
for the quantitive measurement of IgG and IgM class autoantibodies
directed against B-2 glycoprotein mediated anionic phospholipids in

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human serum or plasma,including cardiolipin, phosphatidic
acid,phosphatidyl choline, lyso-phosphaatidyl choline.phosphatidyl
ethanolamine. The assya is intended for in vitro diagnostic use only as
ab aidin the diagnosis of increased risk of thrombosis in patients with
Systemic Lupus Eritematosus(SLE) or similar disorders. Anti
Phospholipids screen kit is intended for laboratory use only.,Anti
Tissue Transglutaminase IgA(Diametra)-Indirect solid phase enzyme
Immunometric assay (Elisa) kit designed for the quantitive
measurement of IgA class antibodies directed against Tissue
transglutaminase in human serum or plasma. The assay is intended
for in vitro diagnostic use only as an aid in the diagnosis of celiac
disease and dermatitis herpetiformis. Anti Tissue Transgulaminase IgA
Kit is intended for laboratory use only.,Throglobulin Elisa(Diametra)-
Immunoenzymatic colorimetric method for quantitative determination
of Throglobulin concentration in human serum. throglobulin Elisa Kit is
intended for laboratory use only.

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643 IMP/IVD/2019/000461 Roche MagNA Pure 96 External Lysis Buffer(MagNA Pure 96 External Lysis CDSCO Class A
Diagnostics India Buffer)-MagNA Pure 96 External Lysis Buffer is a reagent that is used
Pvt. Ltd. in combination with the MagNA Pure 96 System for isolation and
purification of total nucleic acids (DNA/RNA) from biological
specimens for in vitro diagnostic purposes. Any IVD application using
the sample preparation procedure in conjunction with any downstream
IVD nucleic acid testing should be evaluated with regard to the
individual IVD parameter.,MagNA Pure 96 Bacteria Lysis
Buffer(MagNA Pure 96 Bacteria Lysis Buffer)-MagNA Pure 96 External
Lysis Buffer is a reagent that is used in combination with the MagNA
Pure 96 System for isolation and purification of total nucleic acids
(DNA/RNA) from biological specimens for in vitro diagnostic purposes.
Any IVD application using the sample preparation procedure in
conjunction with any downstream IVD nucleic acid testing should be
evaluated with regard to the individual IVD parameter.,MagNA Pure 96
DNA and Viral NA Small Volume Kit(MagNA Pure 96 DNA and Viral
NA Small Volume Kit)-The MagNA Pure 96 DNA and Viral NA Small
Volume Kit is a reagent kit that is used in combination with the MagNA
Pure 96 System for isolation and purification of total nucleic acids
(DNA/RNA) from biological specimens for in vitro diagnostic purposes.
Any IVD application using the sample preparation procedure in
conjunction with any downstream IVD nucleic acid testing should be
evaluated with regard to the individual IVD parameters. ,MagNA Pure
96 DNA Tissue Lysis Buffer(MagNA Pure 96 DNA Tissue Lysis Buffer)-
MagNA Pure 96 DNA Tissue Lysis Buffer is used in combination with
the MagNA Pure 96 System for isolation and purification of total
nucleic acids (DNA/RNA) from biological specimens for in vitro
diagnostic purposes. Any IVD application using the sample
preparation procedure, in conjunction with any downstream IVD
nucleic acid testing, should be evaluated with regard to the individual
IVD parameter.,MagNA Pure 24 Total NA Isolation Kit(MagNA Pure 24
Total NA Isolation Kit)-The MagNA Pure 24 System is an automated
nucleic acid purification system consisting of the MagNA Pure 24
instrument, software, consumables and reagents. The MagNA Pure
24 System is intended for use by professional users for the purification
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of nucleic acids from biological samples for in vitro diagnostic
purposes. The MagNA Pure 24 Total NA Isolation Kit is for use with
the MagNA Pure 24 System.,MagNA Pure 24 MGP Set(MagNA Pure
24 MGP Set)-Used for additional isolations of nucleic acids from
small, large, and extra-large sample volumes,MagNA Pure 96 DNA
and Viral NA Large Volume Kit(MagNA Pure 96 DNA and Viral NA
Large Volume Kit)-The MagNA Pure 96 DNA and Viral NA Large
Volume Kit is a reagent kit that is used in combination with the MagNA
Pure 96 System for isolation and purification of total nucleic acids
(DNA/RNA) from biological specimens for in vitro diagnostic purposes.
Any IVD application using the sample preparation procedure in
conjunction with any downstream IVD nucleic acid testing should be
evaluated with regard to the individual IVD parameters. ,cobas®
Microbial Inactivation Solution(cobas® Microbial Inactivation Solution)-
The cobas® microbial inactivation kit is to be used in conjunction with
the cobas® MTB test on cobas® 6800 and cobas® 8800
Systems,MagNA Pure 96 System Fluid (External)(MagNA Pure 96
System Fluid (External))-The MagNA Pure 96 Instrument is designed
to perform automated purification of nucleic acids for in vitro
diagnostic purposes. The MagNA Pure 96 Instrument is intended to be
used in combination with specified MagNA Pure 96 Kits. The MagNA
Pure 96 System is intended to be used with the defined robotic
workstation, computer ( control unit) with operating software, software
protocol, sample preparation kit and consumables and by professional
users.,MagNA Pure 96 System Fluid (Internal)(MagNA Pure 96
System Fluid (Internal))-The MagNA Pure 96 Instrument is designed
to perform automated purification of nucleic acids for in vitro
diagnostic purposes. The MagNA Pure 96 Instrument is intended to be
used in combination with specified MagNA Pure 96 Kits. The MagNA
Pure 96 System is intended to be used with the defined robotic
workstation, computer ( control unit) with operating software, software
protocol, sample preparation kit and consumables and by professional
users.

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644 IMP/IVD/2019/000462 RAPID DT Wash-To clean probe of medical instruments (DT100, Destiny Max CDSCO Class A
DIAGNOSTIC and Destiny Plus) to make them suitable for an invitro diagnostic
PVT. LTD. procedure,DT Fluid-To clean medical instruments (DT100, Destiny
Max and Destiny Plus) to make them suitable for an in vitro diagnostic
procedure

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645 IMP/IVD/2019/000462 RAPID TriniCLOT PT HTF 20ml-TriniCLOT PT HTF is a tissue thromboplastin CDSCO Class C
DIAGNOSTIC reagent derived from cultured human cells for use in determination of
PVT. LTD. the prothrombin time (PT) in human plasma.,TriniCLOT Factor VII-
TriniCLOT Factor II, V, VII or X Deficient Human Plasma is intended
for the quantitative determination of factor in human plasma by clotting
assay.,TriniCLOT aPTT HS 3ml-TriniCLOT aPTT HS is a phospholipid
reagent with particulate activator for the determination of Activated
Partial Thromboplastin Time (APTT).,TriniCLOT PT HTF 6ml-
TriniCLOT PT HTF is a tissue thromboplastin reagent derived from
cultured human cells for use in determination of the prothrombin time
(PT) in human plasma.,TriniCLOT Automated aPTT 3ml-TriniCLOT
Automated aPTT is a Platelet Factor 3 reagent (partial thromboplastin)
plus particulate activator for the determination of activated partial
thromboplastin times.,TriniCLOT Factor VIII-TriniCLOT Factor VIII, IX,
XI or XII Deficient Human Plasma are intended for the quantitative
determination of factor in human plasma by clotting assay.,TriniCLOT
Factor V-TriniCLOT Factor II, V, VII or X Deficient Human Plasma is
intended for the quantitative determination of factor in human plasma
by clotting assay.,TriniCLOT Fibrinogen 6ml-TriniCLOT Fibrinogen Kit
is intended for quantitative determination of fibrinogen in
plasma.,TriniCLOT Fibrinogen Kit-TriniCLOT Fibrinogen Kit is
intended for quantitative determination of fibrinogen in
plasma.,TriniCLOT Automated aPTT 6ml-TriniCLOT Automated aPTT
is a Platelet Factor 3 reagent (partial thromboplastin) plus particulate
activator for the determination of activated partial thromboplastin
times.,TriniCLOT aPTT HS 10ml-TriniCLOT aPTT HS is a
phospholipid reagent with particulate activator for the determination of
Activated Partial Thromboplastin Time (APTT).,TriniCLOT aPTT S
3ml-TriniCLOT aPTT S is a test kit for use in the determination of the
Activated Partial Thromboplastin Time (APTT) and consists of a
phospholipid reagent with particulate activator and a calcium chloride
reagent.,TriniCLOT aPTT S 10ml-TriniCLOT aPTT S is a test kit for
use in the determination of the Activated Partial Thromboplastin Time
(APTT) and consists of a phospholipid reagent with particulate
activator and a calcium chloride reagent.,TriniCLOT PT Excel 6ml-
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TriniCLOT PT Excel is a tissue thromboplastin reagent (rabbit brain).
TriniCLOT PT Excel is used in a modified one-stage prothrombin time
test.,TriniCLOT PT Excel S 6ml-TriniCLOT PT Excel S is a tissue
thromboplastin reagent (rabbit brain) for use in the determination of
Prothrombin Time (PT) tests.,TriniCLOT PT Excel S 20ml-TriniCLOT
PT Excel S is a tissue thromboplastin reagent (rabbit brain) for use in
the determination of Prothrombin Time (PT) tests.,TriniCLOT
Thrombin Time 4ml-The TriniCLOT Thrombin Time is intended for the
determination of functional fibrinogen in human plasma.,TriniCLOT
Thrombin Time 1ml-The TriniCLOT Thrombin Time is intended for the
determination of functional fibrinogen in human plasma.,TriniCHECK
D-Dimer 3 -TriniCHECK D-Dimer 3 is intended for the quality control
of the TriniLIA D-Dimer, and for the quantitative determination of D-
Dimer in human plasma.,TriniCHECK D-Dimer 2-TriniCHECK D-Dimer
2 is intended for the quality control of the TriniLlA D-Dimer, and for the
quantitative determination of D-Dimer in human plasma.,TriniCHECK
Lupus Positive Control-TriniCHECK Lupus Positive Control is an
assayed abnormal plasma for in vitro diagnostic use in the quality
control of assays for the detection of Lupus Anticoagulant in human
plasma,TriniCHECK Level 3-TriniCHECK Level 2 and TriniCHECK
Level 3 are lyophilized human plasmas in which Factors II, VII, IX, and
X have been selectively and partially removed, to be used as
abnormal controls in the Prothrombin Time (PT) and Activated Partial
Thromboplastin Time (APTT) test procedures.,TriniCHECK Level 2-
TriniCHECK Level 2 and TriniCHECK Level 3 are lyophilized human
plasmas in which Factors II, VII, IX, and X have been selectively and
partially removed, to be used as abnormal controls in the Prothrombin
Time (PT) and Activated Partial Thromboplastin Time (APTT) test
procedures.,TriniCHECK Control 2 (Assayed)-TriniCHECK Control 2
and TriniCHECK Control 3 are lyophilized human plasmas in which
Factors II, VII, IX, and X have been selectively and partially removed
which are intended to be used as assayed control levels for the
following quantitative assays; Prothrombin Time (PT), Activated Partial
Thromboplastin Time (APTT), Fibrinogen (Clauss method), Thrombin
time (TT), Factors II, V, VII, VIII, IX, X, XI, XII Antithrombin (AT) and

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Protein C.,TriniCHROM Factor VIII:c-TriniCHROM Factor VIII:C is
designed for the quantitative determination of Factor VIII:C in human
plasma and Factor VIII concentrate by chromogenic assay,TriniCLOT
Imidazole Buffer-TriniCLOT Imidazole Buffer is a general purpose
laboratory reagent designed for use in coagulation assays such as
fibrinogen and factor assays.,TriniCLOT Factor II-TriniCLOT Factor II,
V, VII or X Deficient Human Plasma is intended for the quantitative
determination of factor in human plasma by clotting
assay.,TriniCHECK D-Dimer 1-TriniCHECK D-Dimer 1 is intended for
the quality control of the TriniLIA D-Dimer, and for the quantitative
determination of D-Dimer in human plasma.,TriniCAL Fibrinogen-
TriniCLOT Fibrinogen Kit is intended for quantitative determination of
fibrinogen in plasma.,TriniVeriCAL-The TriniVeriCAL Calibrator Set is
a set of labelled human plasmas for use with the Destiny Max and
Destiny Plus systems in the in vitro quantification of the Prothrombin
and Activated Partial Thromboplastin coagulation assays. The
TriniVeriCAL Calibrator Set can also be used to verify continued
system and reagent accuracy after calibration.,TriniCAL Reference
Plasma-TriniCAL Reference Plasma is an assayed human plasma
that has been lyophilized to maintain the integrity of the constituents. It
is intended for use as a reference plasma for the quantitation of
coagulation proteins, as well as a control in routine coagulation
assays.,TriniCHECK Level 1-TriniCHECK Level 1 is a lyophilized
human plasma with characteristics similar to those of fresh normal
plasma to be used as a normal control in the Prothrombin Time (PT),
Activated Partial Thromboplastin Time (APTT), and Fibrinogen assay
procedures.,TriniCHECK Abnormal Control-TriniCHECK Abnormal
Control is for use as an assayed plasma control in the testing of
coagulation factors and other plasma components involved in
haemostasis.,TriniCHECK Control 3 (Assayed)-TriniCHECK Control 2
and TriniCHECK Control 3 are lyophilized human plasmas in which
Factors II, VII, IX, and X have been selectively and partially removed
which are intended to be used as assayed control levels for the
following quantitative assays; Prothrombin Time (PT), Activated Partial
Thromboplastin Time (APTT), Fibrinogen (Clauss method), Thrombin

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time (TT), Factors II, V, VII, VIII, IX, X, XI, XII Antithrombin (AT) and
Protein C.,TriniCHECK Control 1 (Assayed)-TriniCHECK Control 1 is
a lyophilized human plasma with characteristics similar to those of
fresh normal plasma which is intended to be used as an assayed
control level for the following quantitative assays; Prothrombin Time
(PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen
(Clauss method), Thrombin time (TT), Factors II, V, VII, VIII, IX, X, XI,
XII, Antithrombin (AT), Protein C, Protein S and Plasminogen.,TriniLIA
D-dimer-TriniLIA D-Dimer kit is a polystyrene, microparticle,
agglutination assay for the quantitative determination of fibrin
degradation products containing DDimer in citrated human plasma
using automated coagulation analyzers.,TriniCHROM Antithrombin
Xa-TriniCHROM Antithrombin Xa (anti-Xa) is intended for the
quantitative determination of Antithrombin (AT) activity in human
citrated plasma by chromogenic assay.,TriniCHROM Antithrombin IIa-
TriniCHROM Antithrombin (AT) IIa is for the quantitative determination
of AT activity in human plasma by a chromogenic assay.,TriniCLOT
Calcium Chloride 0.025M-TriniCLOT Calcium Chloride 0.025 M is a
general purpose laboratory reagent designed for use in coagulation
assays such as APTT and Protein C clotting.,TriniCLOT Factor XII-
TriniCLOT Factor VIII, IX, XI or XII Deficient Human Plasma are
intended for the quantitative determination of factor in human plasma
by clotting assay.,TriniCLOT Factor XI -TriniCLOT Factor VIII, IX, XI or
XII Deficient Human Plasma are intended for the quantitative
determination of factor in human plasma by clotting assay.,TriniCLOT
Factor X-TriniCLOT Factor II, V, VII or X Deficient Human Plasma is
intended for the quantitative determination of factor in human plasma
by clotting assay.,TriniCLOT Factor IX-TriniCLOT Factor VIII, IX, XI or
XII Deficient Human Plasma are intended for the quantitative
determination of factor in human plasma by clotting assay.

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646 IMP/IVD/2019/000463 Siemens Versant HCV Control 2.0 Kit (LiPA)(Versant HCV Control 2.0 Kit CDSCO Class C
Healthcare (LiPA))-The VERSANT® HCV Control 2.0 Kit (LiPA) is designed for
Private Limited use with the VERSANT HCV Amplification 2.0 Kit (LiPA) and the
VERSANT HCV Genotype 2.0 Assay (LiPA) products. The controls
are used for monitoring performance of all steps of the VERSANT
HCV Genotype 2.0 assay. The VERSANT HCV Control 2.0 Kit (LiPA)
is For In Vitro Diagnostic Use.,Versant HCV Amplification 2.0 Kit
(LiPA)(Versant HCV Amplification 2.0 Kit (LiPA))-The VERSANT®
HCV Amplification 2.0 Kit (LiPA) is designed for use in reverse
transcription and amplification of the 5' untranslated region (5'UTR)
and core region of the Hepatitis C Virus (HCV) genome. For in vitro
diagnostic use.,VERSANT ® HCV Genotype 2.0 Assay (LiPA)
(VERSANT ® HCV Genotype 2.0 Assay (LiPA))-The VERSANT®
HCV Genotype 2.0 Assay (LiPA) is a line probe assay, for in vitro
diagnostic use, which identifies Hepatitis C virus (HCV) genotypes 1
to 6 and subtypes a and b of genotype 1 in human serum or EDTA
plasma samples. Additional subtype information is available in a
majority of cases. The product is intended to be used to guide the
selection of treatment type and length for individuals being considered
for antiviral treatment who are chronically infected with HCV. Thus the
kit is intended to be used with samples known to be positive for HCV
RNA. The VERSANT HCV Genotype 2.0 Assay (LiPA) is not intended
to be used as a screening test for HCV or as a diagnostic test to
confirm the presence of HCV. For in vitro diagnostic use.

647 IMP/IVD/2019/000468 Arkray Genedrive® HCV ID Kit(Genedrive® HCV ID Kit)-Genedrive HCV ID CDSCO Class D
Healthcare Pvt., Kit is an in vitro diagnostic test for the rapid qualitative detection of
Ltd Hepatitis C Virus (HCV) RNA in human whole blood derived EDTA
plasma using the Genedrive instrument.

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648 IMP/IVD/2019/000469 RAPID TriniLIA D-Dimer II-TriniLIA D-Dimer II kit is intended for the CDSCO Class C
DIAGNOSTIC quantitative determination of D-Dimer in plasma by the immunoturbidi
PVT. LTD. metric method. It can be used to aid in the diagnosis of deep vein
thrombosis and pulmonary embolism disease.,TriniCHECK LIA
Control Set-TriniCHECK LIA Control Set provides a normal plasma
and an abnormal plasma intended for the quality control of the
following antigenic assays by the immuneturbidimetric method: von
Willebrand factor, free Protein S and D-Dimer.,TriniCLOT PC II-
TriniCLOT PC II kit is intended for the quantitative measurement of the
the functional protein C level based on the prolongation of the
activated partial thromboplastin time (aPTT),TriniCLOT PS II-
TriniCLOT PS II is intended for the quantitative measurement of the
functional protein S level based on the principle of factor Va inhibition
,TriniCAL PC/PS-TriniCAL PC/PS is plasma intended for use as
calibration plasma for the functional assays of Protein C and protein S
by clotting method,TriniCLOT Owren’s Buffer-TriniCLOT Owren’s
Buffer is a buffer solution intended for use as a diluent for reagents
and patient samples in coagulation tests.

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649 IMP/IVD/2019/000470 LIFESCAN Test Strips (OneTouch Select Plus) (OneTouch Select Plus)-The CDSCO Class C
MEDICAL OneTouch Select® Plus Test Strips are used with the OneTouch
DEVICES INDIA Select® Plus Family of Blood Glucose Monitoring Systems (OneTouch
PRIVATE Select® Plus, OneTouch Select Plus Simple®) for the quantitative
LIMITED measurement of glucose (sugar) in fresh capillary whole blood
samples drawn from the fingertips. The OneTouch Select® Plus
Family of Blood Glucose Monitoring Systems is intended to be used
by a single patient and should not be shared. The OneTouch Select®
Plus Family of Blood Glucose Monitoring Systems is not to be used
for the diagnosis of or screening of diabetes or for neonatal use.,Test
Strips (OneTouch Ultra)(OneTouch Ultra)-OneTouch® Ultra™ Test
Strips are used with the OneTouch® Ultra™ Family of Meters for
quantitatively measuring glucose in fresh capillary whole blood. The
OneTouch® Ultra™ Test Strips and associated meters are intended
for use by people with diabetes at home and health care professionals
in the clinical setting. OneTouch® Ultra™ Test Strips and associated
meters are for use in fingertip, palm, and forearm testing.,Test Strips
(OneTouch Verio®) (OneTouch Verio® )-The OneTouch Verio® Test
Strips when used with the OneTouch Verio® Family of Blood Glucose
Monitoring Systems (OneTouch Verio®, OneTouch Verio Flex™) is
intended for the quantitative measurement of glucose (sugar) in fresh
capillary whole blood. Venous whole blood samples may be used by
healthcare professionals with some systems. Refer to your user guide
that came with your meter for sample information. The OneTouch
Verio® Family of Blood Glucose Monitoring Systems are intended for
self-testing outside the body (in vitro diagnostic use) by people with
diabetes at home and by healthcare professionals in a clinical setting
as an aid to monitor the effectiveness of diabetes control. The
OneTouch Verio® Family of Blood Glucose Monitoring Systems is not
to be used for the diagnosis of or screening of diabetes or for neonatal
use.,Test Strips (OneTouch Select)(OneTouch Select )-OneTouch®
Select™ Test Strips are used with the OneTouch® SelectSimple™
Meter for quantitatively measuring glucose in fresh capillary whole
blood. The OneTouch® Select™ Test Strips and meter are intended
for self testing outside the body (in vitro diagnostic use) by people with
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diabetes at home and healthcare professionals in the clinical setting,
as an aid to monitor the effectiveness of diabetes control. OneTouch®
Select™ Test Strips and meter are for use on the finger, palm, and
forearm.

650 IMP/IVD/2019/000474 Siemens Eurotrol Hct Control - Level A(Eurotrol Hct Control - Level A)-Eurotrol CDSCO Class B
Healthcare Hct Control - Level A is an assayed hemotocrit reference material, to
Private Limited verify the precision and accuracy of the epoc Blood Analysis System
for the measurement of hematocrit. ,Epoc Hematocrit Verification
Fluids(Epoc Hematocrit Verification Fluids)-Epoc Hematocrit
Verification Fluids is an assayed hemotocrit reference material, to
verify the precision and accuracy of the epoc Blood Analysis System
for the measurement of hematocrit.,Eurotrol Hct Control - Level
C(Eurotrol Hct Control - Level C)-Eurotrol Hct Control - Level C is an
assayed hemotocrit reference material, to verify the precision and
accuracy of the epoc Blood Analysis System for the measurement of
hematocrit. ,Eurotrol Hct Control - Level B(Eurotrol Hct Control - Level
B)-Eurotrol Hct Control - Level B is an assayed hemotocrit reference
material, to verify the precision and accuracy of the epoc Blood
Analysis System for the measurement of hematocrit.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

651 IMP/IVD/2019/000474 Siemens Eurotrol epoc GAS-ISE Metabolites - Level 2(Eurotrol epoc GAS-ISE CDSCO Class C
Healthcare Metabolites - Level 2)-Eurotrol epoc GAS-ISE Metabolites is a single
Private Limited use, assayed blood gas, electrolyte and metabolite reference material
for the qualitative verification of the precision and accuracy of the
epoc Blood analysis system. The product is an in vitro diagnostic
device, intended for professional laboratory personnel. Eurotrol epoc
GAS-ISE Metabolites is designed to test the following electrolytes: pH,
pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose lactate, urea,
creatinine and tCO2,Eurotrol epoc GAS-ISE Metabolites - Level
3(Eurotrol epoc GAS-ISE Metabolites - Level 3)-Eurotrol epoc GAS-
ISE Metabolites is a single use, assayed, blood gas, electrolyte and
metabolite reference material for the qualitative verification of the
precision and accuracy of the epoc Blood Analysis System. The
product is an in vitro diagnostic device, intended for professional
laboratory personnel. Eurotrol epoc GAS-ISE Metabolites is designed
to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+,
Cl- , Glucose lactate, urea, creatinine and tCO2.,Eurotrol epoc
Calibration Verification Fluids(Eurotrol epoc Calibration Verification
Fluids)-Eurotrol epoc Calibration Verification Fluids is a single use,
assayed, blood gas, electrolyte and metabolite reference material for
the qualitative verification of the precision and accuracy of the epoc
Blood Analysis System. The product is an in vitro diagnostic device,
intended for professional laboratory personnel. Eurotrol epoc
Calibration Verification Fluids is designed to test the following
analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl- , Glucose
lactate, urea, creatinine and tCO2,Eurotrol epoc GAS-ISE Metabolites
- Level 6(Eurotrol epoc GAS-ISE Metabolites - Level 6)-Eurotrol epoc
GAS-ISE Metabolites is a single use, assayed, blood gas, electrolyte
and metabolite reference material for the qualitative verification of the
precision and accuracy of the epoc Blood Analysis System. The
product is an in vitro diagnostic device, intended for professional
laboratory personnel. Eurotrol epoc GAS-ISE Metabolites is designed
to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+,
Cl- , Glucose lactate, urea, creatinine and tCO2.,Eurotrol epoc GAS-
ISE Metabolites - Level 1(Eurotrol epoc GAS-ISE Metabolites - Level
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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
1)-Eurotrol epoc GAS-ISE Metabolites is a single use,assayed blood
gas, electrolyte and metabolite reference material for the qualitative
verification of the precision and accuracy of the epoc Blood Analysis
System. The product is an in vitro diagnostic device,intended for
professional laboratory personnel. Eurotrol epoc GAS-ISE Metabolites
is designed to test the following analytes: pH, pO2, pCO2, Na+, K+,
Ca2+, Mg2+, Cl-, glucose lactate, urea, creatinine and tCO2

652 IMP/IVD/2019/000475 Thermo Fisher Dilution Well-To be used for cleaning of Phadia instruments, with CDSCO Class A
Scientific India Phadia 100 and Phadia 200
Pvt. Ltd.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

653 IMP/IVD/2019/000475 Thermo Fisher Maintenance Solution Kit(Phadia)-Maintenance Solution Kit is CDSCO Class B
Scientific India intended for cleaning of Phadia™ instruments. ,EliA RNA Pol III Well
Pvt. Ltd. (EliA™ )-EliA RNA Pol III is intended for the in vitro quantitative
measurement of IgG antibodies directed to RNA polymerase III (RNA
Pol III) in human serum and plasma as an aid in the clinical diagnosis
of systemic sclerosis (diffuse form). EliA RNA Pol III uses the EliA IgG
method on the Phadia instruments. ,EliA RF Postive Control 250
(EliA™ )-EliA RF IgM is intended for the in vitro quantitative
measurement of IgM rheumatoid factor in serum and plasma to aid in
the diagnosis of rheumatoid arthritis. EliA RF IgM uses the EliA IgM
method on the Phadia instruments. ,EliA RF IgA Well (EliA™ )-EliA RF
IgA is intended for the in vitro quantitative measurement of IgA
rheumatoid factor in serum and plasma to aid in the diagnosis of
rheumatoid arthritis. EliA RF IgA uses the EliA IgA method on the
Phadia instruments. ,EliA PM-Scl Well (EliA™ )-EliA PM-Scl is
intended for the invitro quantitative measurement of IgG antibodies
directed to PM-Scl in human serum and plasma as an aid in the
clinical diagnosis of polymyositis/scleroderma overlap syndrome. EliA
PM-Scl uses the EliA IgG method on the Phadia instruments. ,EliA
PCNA Well (EliA™ )-EliA PCNA is intended for the in vitro quantitative
measurement of IgG antibodies directed to PCNA in human serum
and plasma as an aid in the clinical diagnosis of systemic lupus
erythematosus (SLE). EliA PCNA uses the EliA IgG method on the
Phadia instruments. ,EliA Mi-2 Well (EliA™ )-EliA Mi-2 is intended for
the invitro quantitative measurement of IgG antibodies directed to Mi-2
in human serum and plasma as an aid in the clinical diagnosis of
idopathic (autoimmune) myositis (IM). EliA Mi-2 uses the EliA IgG
method on the Phadia instruments. ,EliA Fibrillarin Well(EliA™ )-EliA
Fibrillarin is intended for the in vitro quantitative measurement of IgG
antibodies directed to fibrillarin in human serum and plasma as an aid
in the clinical diagnosis of systemic sclerosis (Ssc). EliA Fibrillarin
uses the EliA IgG method on the Phadia instruments. ,EliA
Calprotectin Well (EliA™ )-EliA Calprotectin is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Calprotectin Conjugate (EliA™ )-EliA Calprotectin is
intended for the in vitro quantitative measurement of calprotectin in
human stool as an aid in the clinical diagnosis of inflammatory bowel
diseases (IBD). EliA Calprotectin uses the EliA Calprotectin method on
the Phadia instruments. ,EliA Calprotectin Conjugate 50 (EliA™ )-EliA
Calprotectin is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin uses the EliA
Calprotectin method on the Phadia instruments. ,EliA Calprotectin
Conjugate 200 (EliA™ )-EliA Calprotectin is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Calprotectin Calibrator Well (EliA™ )-EliA
Calprotectin is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin uses the EliA
Calprotectin method on the Phadia instruments. ,EliA Calprotectin
Calibrators(EliA™ )-EliA Calprotectin is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Calprotectin Calibrator Strips(EliA™ )-EliA
Calprotectin is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin uses the EliA
Calprotectin method on the Phadia instruments. ,EliA Calprotectin
Curve Control (EliA™ )-EliA Calprotectin is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Calprotectin Curve Control Strips (EliA™ )-EliA
Calprotectin is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
inflammatory bowel diseases (IBD). EliA Calprotectin uses the EliA
Calprotectin method on the Phadia instruments. ,EliA Calprotectin
Positive Control 100 (EliA™ )-EliA Calprotectin is intended for the in
vitro quantitative measurement of calprotectin in human stool as an
aid in the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Calprotectin Negative Control 100 (EliA™ )-EliA
Calprotectin is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin uses the EliA
Calprotectin method on the Phadia instruments. ,EliA Calprotectin
Extraction Buffer (EliA™ )-EliA Calprotectin is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin uses the EliA Calprotectin method on the Phadia
instruments. ,EliA Stool Extraction Kit (EliA™ )-EliA Calprotectin is
intended for the in vitro quantitative measurement of calprotectin in
human stool as an aid in the clinical diagnosis of inflammatory bowel
diseases (IBD). EliA Calprotectin uses the EliA Calprotectin method on
the Phadia instruments. ,ImmunoCAP Specific IgE Anti-
IgE(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Curve Control
Strip(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Curve
Controls,(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Calibrator
Strip 0-100(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Calibrators 0-
100,(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Conjugate
400(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Conjugate
100(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Specific IgE Conjugate 0-
100(ImmunoCAP™)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,Quality Club ECP(ImmunoCAP™)-
Quality Club ECP is a quality assessment program for ImmunoCAP
ECP users. The individual laboratory's continuous performance is
monitored by comparison of test results generated from other
ImmunoCAP ECP users,ImmunoCAP ECP Control(ImmunoCAP™)-
ImmunoCAP ECP Control is used for monitoring ImmunoCAP ECP
measurements performance in Phadia instruments.,ImmunoCAP ECP
Anti-ECP(ImmunoCAP™)-ImmunoCAP ECP is an in vitro test system
for the quantitative measurement of Eosinophil Cationic Protein (ECP)
in human serum. ImmunoCAP ECP is to be used with instruments
Phadia 100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or
Phadia 5000.,ImmunoCAP ECP Curve Control strip(ImmunoCAP™)-
ImmunoCAP ECP is an in vitro test system for the quantitative
measurement of Eosinophil Cationic Protein (ECP) in human serum.
ImmunoCAP ECP is to be used with instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP ECP Curve Control(ImmunoCAP™)-ImmunoCAP
ECP is an in vitro test system for the quantitative measurement of
Eosinophil Cationic Protein (ECP) in human serum. ImmunoCAP ECP
is to be used with instruments Phadia 100, Phadia 200, Phadia 250,
Phadia 1000, Phadia 2500 or Phadia 5000.,ImmunoCAP ECP
Conjugate 50(ImmunoCAP™)-ImmunoCAP ECP is an in vitro test

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
system for the quantitative measurement of Eosinophil Cationic
Protein (ECP) in human serum. ImmunoCAP ECP is to be used with
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP ECP(ImmunoCAP™)-
ImmunoCAP ECP is an in vitro test system for the quantitative
measurement of Eosinophil Cationic Protein (ECP) in human serum.
ImmunoCAP ECP is to be used with instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Specific IgE 0-100(ImmunoCAP™)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP ECP Calibrators
strips(ImmunoCAP™)-ImmunoCAP ECP is an in vitro test system for
the quantitative measurement of Eosinophil Cationic Protein (ECP) in
human serum. ImmunoCAP ECP is to be used with instruments
Phadia 100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or
Phadia 5000.,ImmunoCAP ECP Calibrators(ImmunoCAP™)-
ImmunoCAP ECP is an in vitro test system for the quantitative
measurement of Eosinophil Cationic Protein (ECP) in human serum.
ImmunoCAP ECP is to be used with instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Tryptase Curve Control Strip(ImmunoCAP™)-
ImmunoCAP Tryptase is an in vitro test system for the quantitative
measurement of tryptase in human serum or plasma. It is intended for
in vitro diagnostic use in conjuction with other clinical findings, and is
to be used in clinical laboratories. ImmunoCAP Tryptase is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,ImmunoCAP Tryptase Curve Control(ImmunoCAP™)-
ImmunoCAP Tryptase is an in vitro test system for the quantitative
measurement of tryptase in human serum or plasma. It is intended for
in vitro diagnostic use in conjuction with other clinical findings, and is

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
to be used in clinical laboratories. ImmunoCAP Tryptase is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,ImmunoCAP Tryptase Calibrator Strip(ImmunoCAP™)-
ImmunoCAP Tryptase is an in vitro test system for the quantitative
measurement of tryptase in human serum or plasma. It is intended for
in vitro diagnostic use in conjuction with other clinical findings, and is
to be used in clinical laboratories. ImmunoCAP Tryptase is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,ImmunoCAP Tryptase Calibrators(ImmunoCAP™)-ImmunoCAP
Tryptase is an in vitro test system for the quantitative measurement of
tryptase in human serum or plasma. It is intended for in vitro
diagnostic use in conjuction with other clinical findings, and is to be
used in clinical laboratories. ImmunoCAP Tryptase is to be used with
the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,ImmunoCAP Tryptase Conjugate 50(ImmunoCAP™)-
ImmunoCAP Tryptase is an in vitro test system for the quantitative
measurement of tryptase in human serum or plasma. It is intended for
in vitro diagnostic use in conjuction with other clinical findings, and is
to be used in clinical laboratories. ImmunoCAP Tryptase is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,ImmunoCAP Tryptase(ImmunoCAP™)-ImmunoCAP Tryptase is
an in vitro test system for the quantitative measurement of tryptase in
human serum or plasma. It is intended for in vitro diagnostic use in
conjuction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Tryptase is to be used with the instruments
Phadia 100, Phadia 200, Phadia 250 or Phadia 1000.,"Quality Club
Specific IgE"(ImmunoCAP™)-"Quality Club Specific IgE is a quality
assessment program for ImmunoCAP Specific IgE users. The
individual laboratory's continuous performance is monitored by
comparison of test results generated from other ImmunoCAP Specific
IgE users.",ImmunoCAP Specific IgE Negative
Control(ImmunoCAP™)-"ImmunoCAP Specific IgE Controls are used
for monitoring ImmunoCAP Specific IgE measurements performance
in Phadia instruments",ImmunoCAP Specific IgE Control
H(ImmunoCAP™)-"ImmunoCAP Specific IgE Controls are used for

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
monitoring ImmunoCAP Specific IgE measurements performance in
Phadia instruments",ImmunoCAP Specific IgE Control
M(ImmunoCAP™)-"ImmunoCAP Specific IgE Controls are used for
monitoring ImmunoCAP Specific IgE measurements performance in
Phadia instruments",ImmunoCAP Specific IgE Control
L(ImmunoCAP™)-"ImmunoCAP Specific IgE Controls are used for
monitoring ImmunoCAP Specific IgE measurements performance in
Phadia instruments",ImmunoCAP Tryptase Control(ImmunoCAP™)-
ImmunoCAP Tryptase Control is used for monitoring ImmunoCAP
Tryptase measurements performance in Phadia
instruments.,ImmunoCAP Tryptase Anti-Tryptase(ImmunoCAP™)-
ImmunoCAP Tryptase is an in vitro test system for the quantitative
measurement of tryptase in human serum or plasma. It is intended for
in vitro diagnostic use in conjuction with other clinical findings, and is
to be used in clinical laboratories. ImmunoCAP Tryptase is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250 or Phadia
1000.,EliA CCP IgA Well (EliA™ )-EliA CCP IgA is intended for the in
vitro quantitative measurement of IgA antibodies directed to CCP in
human serum and plasma.The presence of anti-CCP IgA antibodies
can be used in conjunction with clinical findings and other laboratory
tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA).
EliA CCP IgA uses the EliA IgA method on the Phadia instruments.
,EliA RF IgG Well (EliA™ )-EliA RF IgG is intended for the in vitro
quantitative measurement of IgG rheumatoid factor in serum and
plasma to aid in the diagnosis of rheumatoid arthritis. EliA RF IgG
uses the EliA IgG method on the Phadia instruments. ,EliA SmDP Well
(EliA™ )-EliA SmDP is intended for the in vitro quantitative
measurement of IgG antibodies directed to Sm in human serum and
plasma as an aid in the clinical diagnosis of systemic lupus disease
erythematous (SLE) . EliA SmDP uses the EliA IgG method on the
Phadia instruments. ,EliA ssDNA Well (EliA™ )-EliA ssDNA is
intended for the in vitro quantitative measurement of IgG antibodies
directed to ssDNA in human serum and plasma as an aid in the
clinical diagnosis of drug induced lupus disease (DIL). The test is not
definitive in isolation but has to be seen as one parameter in a

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
multicriterion process. EliA ssDNA uses the EliA IgG method on the
Phadia instruments. ,EliA ssDNA Positive Control 250(EliA™ )-EliA
ssDNA is intended for the in vitro quantitative measurement of IgG
antibodies directed to ssDNA in human serum and plasma as an aid in
the clinical diagnosis of drug induced lupus diseases (DIL). The test is
not definitive in isolation but has to be seen as one parameter in a
multicriterion process. EliA ssDNA uses the EliA IgG method on the
Phadia instruments. ,EliA ASCA IgA Well (EliA™ )-"EliA ASCA IgA is
intended for the in vitro quantitative measurement of IgA antibodies
directed to mannan of Saccharomyces cerevisiae in human serum
and plasma as an aid in the clinical diagnosis of Crohn's disease. EliA
ASCA IgA uses the EliA IgA method on the Phadia instruments." ,EliA
ASCA IgG Well (EliA™ )-"EliA ASCA IgG is intended for the in vitro
quantitative measurement of IgG antibodies directed to mannan of
Saccharomyces cerevisiae in human serum and plasma as an aid in
the clinical diagnosis of Crohn's disease. EliA ASCA IgG uses the EliA
IgA method on the Phadia instruments." ,EliA ASCA Postive Control
100 (EliA™ )-"EliA ASCA IgG is intended for the in vitro quantitative
measurement of IgG antibodies directed to mannan of
Saccharomyces cerevisiae in human serum and plasma as an aid in
the clinical diagnosis of Crohn's disease. EliA ASCA IgG uses the EliA
IgA method on the Phadia instruments." ,EliA ASCA Postive Control
250 (EliA™ )-"EliA ASCA IgG is intended for the in vitro quantitative
measurement of IgG antibodies directed to mannan of
Saccharomyces cerevisiae in human serum and plasma as an aid in
the clinical diagnosis of Crohn's disease. EliA ASCA IgG uses the EliA
IgA method on the Phadia instruments." ,EliA Scl-70S Well (EliA™ )-
EliA Scl-70S is intended for the in vitro quantitative measurement of
IgG antibodies directed to Scl-70 in human serum and plasma as an
aid in the clinical diagnosis of scleroderma (diffuse form). EliA Scl-70S
uses the EliA IgGmethod on the Phadia instruments. ,EliA anti-TPO
Well (EliA™ )-EliA anti-TPO is intended for the in vitro quantitative
measurement of IgG antibodies directed to thyroid peroxidase (TPO)
in human serum and plasma as an aid in the clinical diagnosis of
thyroid diseases such as autoimmune thyroiditis and Graves' disease.

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
EliA anti-TPO uses the EliA IgG method on the Phadia instruments.
,EliA Thyroid Positive Control 250 (EliA™ )-EliA anti-TPO is intended
for the in vitro quantitative measurement of IgG antibodies directed to
thyroid peroxidase (TPO) in human serum and plasma as an aid in the
clinical diagnosis of thyroid diseases such as autoimmune thyroiditis
and Graves' disease. EliA anti-TPO uses the EliA IgG method on the
Phadia instruments. ,EliA anti-TG Well (EliA™ )-EliA anti-TG is
intended for the in vitro quantitative measurement of IgG antibodies
directed to thyroglobulin (TG) in human serum and plasma as an aid
in the clinical diagnosis of thyroid diseases such as autoimmune
thyroiditis and Graves' disease. EliA anti-TG uses the EliA IgG method
on the Phadia instruments. ,EliA M2 Well(EliA™ )-EliA M2 is intended
for the in vitro quantitative measurement of IgG antibodies directed to
M2 in human serum and plasma as an aid in the clinical diagnosis of
primary biliary cirrhosis. EliA M2 uses the EliA IgG method on the
Phadia instruments. ,EliA M2 Positive Control 100(EliA™ )-EliA M2 is
intended for the in vitro quantitative measurement of IgG antibodies
directed to M2 in human serum and plasma as an aid in the clinical
diagnosis of primary biliary cirrhosis. EliA M2 uses the EliA IgG
method on the Phadia instruments. ,EliA M2 Positive Control
250(EliA™ )-EliA M2 is intended for the in vitro quantitative
measurement of IgG antibodies directed to M2 in human serum and
plasma as an aid in the clinical diagnosis of primary biliary cirrhosis.
EliA M2 uses the EliA IgG method on the Phadia instruments. ,EliA
Intrinsic Factor Well (EliA™ )-EliA Intrinsic factor is intended for the in
vitro quantitative measurement of IgG antibodies directed to intrinsic
factor in human serum and plasma to aid in the clinical diagnosis of
pernicious anemia. EliA Intrinsic Factor uses the EliA IgG method on
the Phadia instruments. ,EliA Gastric Positive Control 250 (EliA™ )-
EliA Intrinsic factor is intended for the in vitro quantitative
measurement of IgG antibodies directed to intrinsic factor in human
serum and plasma to aid in the clinical diagnosis of pernicious
anemia. EliA Intrinsic Factor uses the EliA IgG method on the Phadia
instruments. ,EliA Parietal Cell Well (EliA™ )-EliA Parietal Cell is
intended for the in vitro quantitative measurement of IgG antibodies

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
directed to in human serum and plasma as an aid in the clinical
diagnosis of pernicious anemia EliA Parietal Cell uses the EliA IgG
method on the Phadia instruments. ,EliA Calprotectin 2 Well (EliA™ )-
EliA Calprotectin 2 is intended for the in vitro quantitative
measurement of calprotectin in human stool as an aid in the clinical
diagnosis of inflammatory bowel diseases (IBD). EliA Calprotectin 2
uses the EliA Calprotectin 2 method on the Phadia instruments. ,EliA
Calprotectin 2 Conjugate 50(EliA™ )-EliA Calprotectin 2 is intended
for the in vitro quantitative measurement of calprotectin in human stool
as an aid in the clinical diagnosis of inflammatory bowel diseases
(IBD). EliA Calprotectin 2 uses the EliA Calprotectin 2 method on the
Phadia instruments. ,EliA Calprotectin 2 Conjugate 200(EliA™ )-EliA
Calprotectin 2 is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin 2 uses the EliA
Calprotectin 2 method on the Phadia instruments. ,EliA Calprotectin 2
Calibrator Well(EliA™ )-EliA Calprotectin 2 is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin 2 uses the EliA Calprotectin 2 method on the Phadia
instruments. ,EliA Calprotectin 2 Calibrator Strips(EliA™ )-EliA
Calprotectin 2 is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin 2 uses the EliA
Calprotectin 2 method on the Phadia instruments. ,EliA Calprotectin 2
Curve Control Strips(EliA™ )-EliA Calprotectin 2 is intended for the in
vitro quantitative measurement of calprotectin in human stool as an
aid in the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin 2 uses the EliA Calprotectin 2 method on the Phadia
instruments. ,EliA Calprotectin Positive Control 250 (EliA™ )-EliA
Calprotectin 2 is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin 2 uses the EliA
Calprotectin 2 method on the Phadia instruments. ,EliA Calprotectin
Negative Control 250 (EliA™ )-EliA Calprotectin 2 is intended for the

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
in vitro quantitative measurement of calprotectin in human stool as an
aid in the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin 2 uses the EliA Calprotectin 2 method on the Phadia
instruments. ,EliA Calprotectin 2 Extraction Buffer(EliA™ )-EliA
Calprotectin 2 is intended for the in vitro quantitative measurement of
calprotectin in human stool as an aid in the clinical diagnosis of
inflammatory bowel diseases (IBD). EliA Calprotectin 2 uses the EliA
Calprotectin 2 method on the Phadia instruments. ,EliA Stool
Extraction Kit 2(EliA™ )-EliA Calprotectin 2 is intended for the in vitro
quantitative measurement of calprotectin in human stool as an aid in
the clinical diagnosis of inflammatory bowel diseases (IBD). EliA
Calprotectin 2 uses the EliA Calprotectin 2 method on the Phadia
instruments. ,EliA U1RNP Well(EliA™ )-"EliA U1RNP is intended for
the in vitro quantitative measurement of IgG antibodies directed to
U1RNP in human serum and plasma as an aid in the clinical diagnosis
of mixed connective tissue disease (MCTD) and systemic lupus
erythematosus (SLE). EliA U1RNP uses the EliA IgG method on the
Phadia Instruments." ,EliA IgG Conjugate 50 (EliA™ )-EliA dsDNA is
intended for the in vitro quantitative measurement of IgG antibodies
directed to dsDNA in human serum and plasma as an aid in the
clinical diagnosis of systemic lupus erythematosus (SLE). EliA dsDNA
uses the EliA IgG method on the Phadia instruments. ,EliA IgG
Conjugate 200 (EliA™ )-EliA dsDNA is intended for the in vitro
quantitative measurement of IgG antibodies directed to dsDNA in
human serum and plasma as an aid in the clinical diagnosis of
systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG
method on the Phadia instruments. ,EliA IgG Calibrator Well (EliA™ )-
EliA dsDNA is intended for the in vitro quantitative measurement of
IgG antibodies directed to dsDNA in human serum and plasma as an
aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
EliA dsDNA uses the EliA IgG method on the Phadia instruments.
,EliA IgG Calibrators(EliA™ )-EliA dsDNA is intended for the in vitro
quantitative measurement of IgG antibodies directed to dsDNA in
human serum and plasma as an aid in the clinical diagnosis of
systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
method on the Phadia instruments. ,EliA IgG Calibrator Strips
(EliA™ )-EliA dsDNA is intended for the in vitro quantitative
measurement of IgG antibodies directed to dsDNA in human serum
and plasma as an aid in the clinical diagnosis of systemic lupus
erythematosus (SLE). EliA dsDNA uses the EliA IgG method on the
Phadia instruments. ,EliA IgG Curve Control (EliA™ )-EliA dsDNA is
intended for the in vitro quantitative measurement of IgG antibodies
directed to dsDNA in human serum and plasma as an aid in the
clinical diagnosis of systemic lupus erythematosus (SLE). EliA dsDNA
uses the EliA IgG method on the Phadia instruments. ,EliA IgG Curve
Control Strips (EliA™ )-EliA dsDNA is intended for the in vitro
quantitative measurement of IgG antibodies directed to dsDNA in
human serum and plasma as an aid in the clinical diagnosis of
systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG
method on the Phadia instruments. ,EliA ANA Positive Control 100
(EliA™ )-EliA dsDNA is intended for the in vitro quantitative
measurement of IgG antibodies directed to dsDNA in human serum
and plasma as an aid in the clinical diagnosis of systemic lupus
erythematosus (SLE). EliA dsDNA uses the EliA IgG method on the
Phadia instruments. ,EliA ANA Positive Control 250 (EliA™ )-EliA
dsDNA is intended for the in vitro quantitative measurement of IgG
antibodies directed to dsDNA in human serum and plasma as an aid
in the clinical diagnosis of systemic lupus erythematosus (SLE). EliA
dsDNA uses the EliA IgG method on the Phadia instruments. ,EliA
IgG/IgA/IgM Negative Control 100 (EliA™ )-EliA dsDNA is intended for
the in vitro quantitative measurement of IgG antibodies directed to
dsDNA in human serum and plasma as an aid in the clinical diagnosis
of systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG
method on the Phadia instruments. ,EliA IgG/IgA/IgM Negative Control
250 (EliA™ )-EliA dsDNA is intended for the in vitro quantitative
measurement of IgG antibodies directed to dsDNA in human serum
and plasma as an aid in the clinical diagnosis of systemic lupus
erythematosus (SLE). EliA dsDNA uses the EliA IgG method on the
Phadia instruments. ,EliA Ro52 Well (EliA™ )-EliA Ro52 is intended
for the in vitro quantitative measurement of IgG antibodies directed

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Ro52 in human serum and plasma as an aid in the clinical diagnosis
of Sjogren's syndrome and systemic lupus erythematosus (SLE). EliA
Ro52 uses the EliA IgG method on the Phadia instruments. ,EliA
Sample Diluent (EliA™ )-EliA dsDNA is intended for the in vitro
quantitative measurement of IgG antibodies directed to dsDNA in
human serum and plasma as an aid in the clinical diagnosis of
systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG
method on the Phadia instruments. ,EliA Quality Club
Autoimmunity(EliA™ )-"EliA Quality Club Autoimmunity is a quality
assessment program for Phadia Instrument users. The individual
laboratory's continuous performance is monitored by comparison of
test results generated from other Phadia Instrument users." ,EliA Ro
Well (EliA™ )-"EliA Ro is intended for the in vitro quantitative
measurement of IgG antibodies directed to Ro in human serum and
plasma as an aid in the clinical diagnosis of Sjögren's syndrome and
systemic lupus erythematosus (SLE). EliA Ro uses the EliA IgG
method on the Phadia instruments." ,EliA La Well (EliA™ )-"EliA La is
intended for the in vitro quantitative measurement of IgG antibodies
directed to La in human serum and plasma as an aid in the clinical
diagnosis of Sjögren's syndrome and systemic lupus erythematosus
(SLE). EliA La uses the EliA IgG method on the Phadia instruments."
,EliA CENP Well (EliA™ )-"EliA CENP is intended for the in vitro
quantitative measurement of IgG antibodies directed to CENP in
human serum and plasma as an aid in the clinical diagnosis of
scleroderma (CREST Syndrome). EliA CENP uses the EliA IgG
method on the Phadia instruments." ,EliA IgA Conjugate ( EliA™ )-EliA
Celikey IgA is intended for the in vitro quantitative measurement of IgA
antibodies directed to tissue transglutaminase (tTG) in human serum
and plasma. EliA Celikey IgA is based on recombinant human tissue
transglutaminase as antigen and is useful as an aid in the clinical
diagnosis of patients with celiac disease. EliA Celikey IgA uses the
EliA IgA method on the Phadia instruments. ,EliA IgA Conjugate 50 (
EliA™ )-EliA Celikey IgA is intended for the in vitro quantitative
measurement of IgA antibodies directed to tissue transglutaminase
(tTG) in human serum and plasma. EliA Celikey IgA is based on

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
recombinant human tissue transglutaminase as antigen and is useful
as an aid in the clinical diagnosis of patients with celiac disease. EliA
Celikey IgA uses the EliA IgA method on the Phadia instruments. ,EliA
IgA Conjugate 200 ( EliA™ )-EliA Celikey IgA is intended for the in
vitro quantitative measurement of IgA antibodies directed to tissue
transglutaminase (tTG) in human serum and plasma. EliA Celikey IgA
is based on recombinant human tissue transglutaminase as antigen
and is useful as an aid in the clinical diagnosis of patients with celiac
disease. EliA Celikey IgA uses the EliA IgA method on the Phadia
instruments. ,EliA IgA Calibrator Well ( EliA™ )-EliA Celikey IgA is
intended for the in vitro quantitative measurement of IgA antibodies
directed to tissue transglutaminase (tTG) in human serum and
plasma. EliA Celikey IgA is based on recombinant human tissue
transglutaminase as antigen and is useful as an aid in the clinical
diagnosis of patients with celiac disease. EliA Celikey IgA uses the
EliA IgA method on the Phadia instruments. ,EliA IgA Calibrators(
EliA™ )-EliA Celikey IgA is intended for the in vitro quantitative
measurement of IgA antibodies directed to tissue transglutaminase
(tTG) in human serum and plasma. EliA Celikey IgA is based on
recombinant human tissue transglutaminase as antigen and is useful
as an aid in the clinical diagnosis of patients with celiac disease. EliA
Celikey IgA uses the EliA IgA method on the Phadia instruments. ,EliA
IgA Calibrator Strips( EliA™ )-EliA Celikey IgA is intended for the in
vitro quantitative measurement of IgA antibodies directed to tissue
transglutaminase (tTG) in human serum and plasma. EliA Celikey IgA
is based on recombinant human tissue transglutaminase as antigen
and is useful as an aid in the clinical diagnosis of patients with celiac
disease. EliA Celikey IgA uses the EliA IgA method on the Phadia
instruments. ,EliA IgA Curve Controls( EliA™ )-EliA Celikey IgA is
intended for the in vitro quantitative measurement of IgA antibodies
directed to tissue transglutaminase (tTG) in human serum and
plasma. EliA Celikey IgA is based on recombinant human tissue
transglutaminase as antigen and is useful as an aid in the clinical
diagnosis of patients with celiac disease. EliA Celikey IgA uses the
EliA IgA method on the Phadia instruments. ,EliA IgA Curve Control

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Strips ( EliA™ )-EliA Celikey IgA is intended for the in vitro quantitative
measurement of IgA antibodies directed to tissue transglutaminase
(tTG) in human serum and plasma. EliA Celikey IgA is based on
recombinant human tissue transglutaminase as antigen and is useful
as an aid in the clinical diagnosis of patients with celiac disease. EliA
Celikey IgA uses the EliA IgA method on the Phadia instruments. ,EliA
Celiac Positive Control 100( EliA™ )-EliA Celikey IgA is intended for
the in vitro quantitative measurement of IgA antibodies directed to
tissue transglutaminase (tTG) in human serum and plasma. EliA
Celikey IgA is based on recombinant human tissue transglutaminase
as antigen and is useful as an aid in the clinical diagnosis of patients
with celiac disease. EliA Celikey IgA uses the EliA IgA method on the
Phadia instruments. ,EliA Celiac Positive Control 250( EliA™ )-EliA
Celikey IgA is intended for the in vitro quantitative measurement of IgA
antibodies directed to tissue transglutaminase (tTG) in human serum
and plasma. EliA Celikey IgA is based on recombinant human tissue
transglutaminase as antigen and is useful as an aid in the clinical
diagnosis of patients with celiac disease. EliA Celikey IgA uses the
EliA IgA method on the Phadia instruments. ,EliA Celikey IgG Well(
EliA™ )-EliA Celikey IgG is intended for the in vitro quantitative
measurement of IgG antibodies directed to tissue transglutaminase
(tTG) in human serum and plasma. EliA Celikey IgG is based on
recombinant human tissue transglutaminase as antigen and is useful
as an aid in the clinical diagnosis of patients with celiac disease. EliA
Celikey IgG uses the EliA IgG method on the Phadia instruments.
,EliA Gliadin IgA Well (EliA™ )-EliA Gliadin IgA is intended for the in
vitro quantitative measurement of IgA antibodies directed to gliadin in
serum or plasma to aid in the diagnosis of celiac disease. EliA Gliadin
IgA uses the EliA IgA method on the Phadia instruments. ,EliA Gliadin
IgG Well (EliA™ )-EliA Gliadin IgG is intended for the in vitro
quantitative measurement of IgG antibodies directed to gliadin in
serum or plasma to aid in the diagnosis of celiac disease. EliA Gliadin
IgG uses the EliA IgG method on the Phadia instruments. ,EliA Rib-P
Well (EliA™ )-EliA Rib-P is intended for the in vitro quantitative
measurement of IgG antibodies directed to Rib-P in human serum and

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
plasma as an aid in the clinical diagnosis of rheumatoid arthritis. EliA
RF IgM uses the EliA IgM method on the Phadia instruments. ,EliA
ANCA/GBM Positive Control 250(EliA™ )-"EliA MPOS is intended for
the in vitro quantitative measurement of IgG antibodies directed to
myeloperoxidase (MPO) in human serum and plasma as an aid in the
clinical diagnosis of microscopic polyangiitis (MPA). EliA MPOS uses
the EliA IgG method on the Phadia instruments." ,EliA ANCA/GBM
Positive Control 100(EliA™ )-"EliA MPOS is intended for the in vitro
quantitative measurement of IgG antibodies directed to
myeloperoxidase (MPO) in human serum and plasma as an aid in the
clinical diagnosis of microscopic polyangiitis (MPA). EliA MPOS uses
the EliA IgG method on the Phadia instruments." ,EliA MPOS
Well(EliA™ )-"EliA MPOS is intended for the in vitro quantitative
measurement of IgG antibodies directed to myeloperoxidase (MPO) in
human serum and plasma as an aid in the clinical diagnosis of
microscopic polyangiitis (MPA). EliA MPOS uses the EliA IgG method
on the Phadia instruments." ,EliA PR3S Well(EliA™ )-"EliA PR3S is
intended for the in vitro quantitative measurement of IgG antibodies
directed to proteinase 3 (PR3) in human serum and plasma as an aid
in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA,
formally called Wegener's Granulomatosis). EliA PR3S uses the EliA
IgG method on the Phadia instruments." ,EliA Celikey IgA Well( EliA™
)-EliA Celikey IgA is intended for the in vitro quantitative measurement
of IgA antibodies directed to tissue transglutaminase (tTG) in human
serum and plasma. EliA Celikey IgA is based on recombinant human
tissue transglutaminase as antigen and is useful as an aid in the
clinical diagnosis of patients with celiac disease. EliA Celikey IgA uses
the EliA IgA method on the Phadia instruments. ,EliA CCP Positive
Control 250( EliA™ )-"EliA CCP is intended for the in vitro quantitative
measurement of IgG antibodies directed to CCP in human serum and
plasma. The presence of anti-CCP antibodies can be used in
conjunction with clinical findings and other laboratory tests as an aid in
the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the
the EliA IgG method on the Phadia instruments." ,EliA CCP Positive
Control 100( EliA™ )-"EliA CCP is intended for the in vitro quantitative

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
measurement of IgG antibodies directed to CCP in human serum and
plasma. The presence of anti-CCP antibodies can be used in
conjunction with clinical findings and other laboratory tests as an aid in
the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the
the EliA IgG method on the Phadia instruments." ,EliA GBM Well
(EliA™ )-"The EliA GBM Wells are part of the EliA IgG System. They
are intended for the in vitro quantitative measurement of IgG
antibodies to α3 chain of collagen IV in human serum and plasma as an
aid in the clinical diagnosis of Goodpasture syndrome and anti-GBM
disease. EliA GBM uses the EliA IgG method on the Phadia
instruments." ,EliA RNP70 Well (EliA™ )-"EliA RNP70 is intended for
the in vitro quantitative measurement of IgG antibodies directed to
RNP70 in human serum and plasma as an aid in the clinical diagnosis
of mixed connective tissue disease (MCTD) and systemic lupus
erythematosus (SLE). EliA RNP70 uses the EliA IgG method on the
Phadia instruments." ,EliA Ro60 Well (EliA™ )-EliA Ro60 is intended
for the in vitro quantitative measurement of IgG antibodies directed
Ro60 in human serum and plasma as an aid in the clinical diagnosis
of Sjogren's syndrome and systemic lupus erythematosus (SLE). EliA
Ro60 uses the EliA IgG method on the Phadia instruments. ,EliA
Cardiolipin IgA Well(EliA™)-EliA Cardiolipin IgA is intended for the in
vitro quantitative measurement of IgA antibodies directed to cardiolipin
in serum and plasma to aid in the diagnosis of antiphospholipid
syndrome (APS) and to evaluate the thrombotic risk in patients with
systemic lupus erythematosus (SLE). EliA Cardiolipin IgA uses the the
EliA IgA method on the Phadia instruments. ,EliA Cardiolipin IgG
Well(EliA™)-EliA Cardiolipin IgG is intended for the in vitro
quantitative measurement of IgG antibodies directed to cardiolipin in
serum and plasma to aid in the diagnosis of antiphospholipid
syndrome (APS) and to evaluate the thrombotic risk in patients with
systemic lupus erythematosus (SLE). EliA Cardiolipin IgG uses the the
EliA IgG method on the Phadia instruments. ,EliA Cardiolipin IgM
Well(EliA™)-"EliA Cardiolipin IgM is intended for the in vitro
quantitative measurement of IgM antibodies directed to cardiolipin in
serum and plasma to aid in the diagnosis of antiphospholipid

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
syndrome (APS) and to evaluate the thrombotic risk in patients with
systemic lupus erythematosus (SLE). EliA Cardiolipin IgM uses the
the EliA IgM method on the Phadia instruments." ,EliA IgM
Conjugate(EliA™ )-"EliA Cardiolipin IgM is intended for the in vitro
quantitative measurement of IgM antibodies directed to cardiolipin in
serum and plasma to aid in the diagnosis of antiphospholipid
syndrome (APS) and to evaluate the thrombotic risk in patients with
systemic lupus erythematosus (SLE). EliA Cardiolipin IgM uses the
the EliA IgM method on the Phadia instruments." ,EliA IgM Conjugate
50(EliA™ )-"EliA Cardiolipin IgM is intended for the in vitro quantitative
measurement of IgM antibodies directed to cardiolipin in serum and
plasma to aid in the diagnosis of antiphospholipid syndrome (APS)
and to evaluate the thrombotic risk in patients with systemic lupus
erythematosus (SLE). EliA Cardiolipin IgM uses the the EliA IgM
method on the Phadia instruments." ,EliA IgM Conjugate 200(EliA™)-
"EliA Cardiolipin IgM is intended for the in vitro quantitative
measurement of IgM antibodies directed to cardiolipin in serum and
plasma to aid in the diagnosis of antiphospholipid syndrome (APS)
and to evaluate the thrombotic risk in patients with systemic lupus
erythematosus (SLE). EliA Cardiolipin IgM uses the the EliA IgM
method on the Phadia instruments." ,EliA IgM Calibrator Well(EliA™)-
"EliA Cardiolipin IgM is intended for the in vitro quantitative
measurement of IgM antibodies directed to cardiolipin in serum and
plasma to aid in the diagnosis of antiphospholipid syndrome (APS)
and to evaluate the thrombotic risk in patients with systemic lupus
erythematosus (SLE). EliA Cardiolipin IgM uses the the EliA IgM
method on the Phadia instruments." ,EliA IgM Calibrators(EliA™)-"EliA
Cardiolipin IgM is intended for the in vitro quantitative measurement of
IgM antibodies directed to cardiolipin in serum and plasma to aid in
the diagnosis of antiphospholipid syndrome (APS) and to evaluate the
thrombotic risk in patients with systemic lupus erythematosus (SLE).
EliA Cardiolipin IgM uses the the EliA IgM method on the Phadia
instruments." ,EliA IgM Calibrator Strips(EliA™)-"EliA Cardiolipin IgM
is intended for the in vitro quantitative measurement of IgM antibodies
directed to cardiolipin in serum and plasma to aid in the diagnosis of

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
antiphospholipid syndrome (APS) and to evaluate the thrombotic risk
in patients with systemic lupus erythematosus (SLE). EliA Cardiolipin
IgM uses the the EliA IgM method on the Phadia instruments." ,EliA
IgM Curve Control(EliA™)-"EliA Cardiolipin IgM is intended for the in
vitro quantitative measurement of IgM antibodies directed to
cardiolipin in serum and plasma to aid in the diagnosis of
antiphospholipid syndrome (APS) and to evaluate the thrombotic risk
in patients with systemic lupus erythematosus (SLE). EliA Cardiolipin
IgM uses the the EliA IgM method on the Phadia instruments." ,EliA
IgM Curve Control Strips(EliA™)-"EliA Cardiolipin IgM is intended for
the in vitro quantitative measurement of IgM antibodies directed to
cardiolipin in serum and plasma to aid in the diagnosis of
antiphospholipid syndrome (APS) and to evaluate the thrombotic risk
in patients with systemic lupus erythematosus (SLE). EliA Cardiolipin
IgM uses the the EliA IgM method on the Phadia instruments." ,EliA
APS Positive Control 100(EliA™)-"EliA Cardiolipin IgM is intended for
the in vitro quantitative measurement of IgM antibodies directed to
cardiolipin in serum and plasma to aid in the diagnosis of
antiphospholipid syndrome (APS) and to evaluate the thrombotic risk
in patients with systemic lupus erythematosus (SLE). EliA Cardiolipin
IgM uses the the EliA IgM method on the Phadia instruments." ,EliA
APS Positive Control 250(EliA™)-"EliA Cardiolipin IgM is intended for
the in vitro quantitative measurement of IgM antibodies directed to
cardiolipin in serum and plasma to aid in the diagnosis of
antiphospholipid syndrome (APS) and to evaluate the thrombotic risk
in patients with systemic lupus erythematosus (SLE). EliA Cardiolipin
IgM uses the the EliA IgM method on the Phadia instruments." ,EliA
ß2-Glycoprotein I IgA Well (EliA™ )-"EliA ß2-Glycoprotein I I IgA is
intended for the invitro quantitative measurement of IgA antibodies
directed to ß2-Glycoprotein Iin human serum and plasma as an aid in
the diagnosis of antiphopholipid syndrome (APS)to evaluate the
thrombotic risk in pateints with systemic lupus erythematosus (SLE).
EliA ß2-Glycoprotein IIgA uses the EliA IgA method on the Phadia
instruments." ,EliA ß2-Glycoprotein I IgG Well (EliA™ )-"EliA ß2-
Glycoprotein I IgG is intended for the invitro quantitative measurement

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
of IgG antibodies directed to ß2-Glycoprotein Iin human serum and
plasma as an aid in the diagnosis of antiphopholipid syndrome
(APS)to evaluate the thrombotic risk in pateints with systemic lupus
erythematosus (SLE). EliA ß2-Glycoprotein I IgG uses the EliA IgG
method on the Phadia instruments." ,EliA ß2-Glycoprotein I
IgM(EliA™ )-"EliA ß2-Glycoprotein I IgM is intended for the invitro
quantitative measurement of IgA antibodies directed to ß2-
Glycoprotein I in human serum and plasma as an aid in the diagnosis
of antiphopholipid syndrome (APS)to evaluate the thrombotic risk in
pateints with systemic lupus erythematosus (SLE). EliA ß2-
Glycoprotein I IgM uses the EliA IgA method on the Phadia
instruments." ,EliA Anti-IgA Well (EliA™ )-EliA Anti-IgA is intendeed for
the in vitro quantitative measurement of IgAG antibodies directed to
IgA in human serum or plasma. EliA Anti-IgA uses the EliA IgG method
on the Phadia instruments. ,EliA Anti-IgA Positive Control
100(EliA™ )-EliA Anti-IgA is intendeed for the in vitro quantitative
measurement of IgA antibodies directed to IgA in human serum or
plasma. EliA Anti-IgA uses the EliA IgG method on the Phadia
instruments. ,EliA GliadinDP IgA Well (EliA™ )-EliA Gliadin IgA is
intended for the in vitro quantitative measurement of IgA antibodies
directed to gliadin in serum or plasma to aid in the diagnosis of celiac
disease. EliA Gliadin IgA uses the EliA IgA method on the Phadia
instruments. ,EliA GliadinDP IgG Well (EliA™ )-EliA Gliadin IgG is
intended for the in vitro quantitative measurement of IgG antibodies
directed to gliadin in serum or plasma to aid in the diagnosis of celiac
disease. EliA Gliadin IgG uses the EliA IgG method on the Phadia
instruments. ,EliA CTD Screen Well(EliA™ )-"EliA CTD Screen is
intended for the in vitro qualitative measurement of antinuclear IgG
antibodies in human serum and plasma as an aid in the clinical
diagnosis of systemic lupus erythematosus (SLE), mixed connective
tissue disease (MCTD), Sjögren's syndrome, scleroderma and
polymyositis/dermatomyositis. EliA CTD Screen uses the EliA IgG
method on the Phadia instruments." ,EliA Symphony Well (EliA™ )-
"EliA Symphony is intended for the in vitro quantitative measurement
of antinucelar IgG antibodies in human serum and plasma as an aid in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
the clinical diagnosis of systemic lupus erythematosus (SLE), mixede
connective tissue disease (MCTD), Sjogren's syndrome, scleroderma
and polymyositis/dermatomyositis. EliA Symphony uses the EliA IgG
method on the Phadia instruments." ,EliA IgG Conjugate (EliA™ )-EliA
dsDNA is intended for the in vitro quantitative measurement of IgG
antibodies directed to dsDNA in human serum and plasma as an aid
in the clinical diagnosis of systemic lupus erythematosus (SLE). EliA
dsDNA uses the EliA IgG method on the Phadia instruments. ,EliA
dsDNA Well (EliA™ )-EliA dsDNA is intended for the in vitro
quantitative measurement of IgG antibodies directed to dsDNA in
human serum and plasma as an aid in the clinical diagnosis of
systemic lupus erythematosus (SLE). EliA dsDNA uses the EliA IgG
method on the Phadia instruments. ,EliA Anti-IgA Positive Control
250(EliA™ )-EliA Anti-IgA is intendeed for the in vitro quantitative
measurement of IgA antibodies directed to IgA in human serum or
plasma. EliA Anti-IgA uses the EliA IgG method on the Phadia
instruments. ,EliA Jo-1 Well (EliA™ )-EliA Jo-1 is intended for the in
vitro quantitative measurement of IgG antibodies directed to Jo-1 in
human serum and plasma as an aid in the clinical diagnosis of
polymyositis / dermatomyositis. EliA Jo-1 uses the EliA IgG method on
the Phadia instruments. ,EliA RF Positive Control 100 (EliA™ )-EliA
RF IgM is intended for the in vitro quantitative measurement of IgM
rheumatoid factor in serum and plasma to aid in the diagnosis of
rheumatoid arthritis. EliA RF IgM uses the EliA IgM method on the
Phadia instruments. ,EliA RF IgM Well (EliA™ )-EliA RF IgM is
intended for the in vitro quantitative measurement of IgM rheumatoid
factor in serum and plasma to aid in the diagnosis of rheumatoid
arthritis. EliA RF IgM uses the EliA IgM method on the Phadia
instruments. ,ImmunoCAP Allergen f25, Tomato(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.,Stop
Solution(ImmunoCAP™)-Stop Solution is to be used in ImmunoCAP
or EliA assays.,ImmunoCAP IgE/ECP/Tryptase Sample
Diluent(ImmunoCAP™)-"To be used with In vitro test for quantitative
measurement of IgE/ECP/Tryptase in Phadia
Instrument",ImmunoCAP Total IgE Curve Controls(ImmunoCAP™)-
"ImmunoCAP Total IgE is an in vitro test system for the quantitative
measurement of circulating total IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP Total
IgE is to be used with the instruments Phadia 100, Phadia 200,
Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",ImmunoCAP Total IgE Calibrators(ImmunoCAP™)-
"ImmunoCAP Total IgE is an in vitro test system for the quantitative
measurement of circulating total IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP Total
IgE is to be used with the instruments Phadia 100, Phadia 200,
Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",ImmunoCAP Total IgE Calibrator Strip(ImmunoCAP™)-
"ImmunoCAP Total IgE is an in vitro test system for the quantitative
measurement of circulating total IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP Total
IgE is to be used with the instruments Phadia 100, Phadia 200,
Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",ImmunoCAP Total IgE Anti-IgE(ImmunoCAP™)-"ImmunoCAP
Total IgE is an in vitro test system for the quantitative measurement of
circulating total IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Total IgE is to be used

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadian
1000,Phadia 2500 or Phadia 5000.",ImmunoCAP Total IgE Curve
Controls Strips(ImmunoCAP™)-"ImmunoCAP Total IgE is an in vitro
test system for the quantitative measurement of circulating total IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Total IgE is to be used with the instruments
Phadia 100, Phadia 200, Phadia 250, Phadian 1000,Phadia 2500 or
Phadia 5000.",ImmunoCAP Total IgE Control LMH(ImmunoCAP™)-
"ImmunoCAP Total IgE is an in vitro test system for the quantitative
measurement of circulating total IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP Total
IgE is to be used with the instruments Phadia 100, Phadia 200,
Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",ImmunoCAP Total IgE Conjugate 400(ImmunoCAP™)-
"ImmunoCAP Total IgE is an in vitro test system for the quantitative
measurement of circulating total IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP Total
IgE is to be used with the instruments Phadia 100, Phadia 200,
Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",ImmunoCAP Total IgE(ImmunoCAP™)-"ImmunoCAP Total IgE
is an in vitro test system for the quantitative measurement of
circulating total IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Total IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadian
1000,Phadia 2500 or Phadia 5000.",ImmunoCAP Total IgE Conjugate
100(ImmunoCAP™)-"ImmunoCAP Total IgE is an in vitro test system
for the quantitative measurement of circulating total IgE in human

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Total IgE is to be used with the instruments Phadia 100,
Phadia 200, Phadia 250, Phadian 1000,Phadia 2500 or Phadia
5000.",Washing Solution(ImmunoCAP™)-Washing Solution is to be
used in ImmunoCAP or EliA assays,Development
Solution(ImmunoCAP™)-Development Solution is to be used in
ImmunoCAP or EliA assays.,Quality Club Total IgE(ImmunoCAP™)-
"Quality Club Total IgE is a quality assessment program for
ImmunoCAP Total IgE users. The individual laboratory's continuous
performance is monitored by comparison of test results generated
from other ImmunoCAP Total IgE users",ImmunoCAP Allergen t19,
Acacia(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f33,
Orange(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g1, Sweet vernal
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g2, Bermuda
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f9,
Rice(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f10, Sesame seed(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f12, Pea(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f15, White
bean(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f18, Brazil nut(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f20,
Almond(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f23,
Crab(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f24, Shrimp(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f26,
Pork(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f75, Egg yolk(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f83,
Chicken(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g17, Bahia
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen gx2, Grass
pollen(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen wx1, Weed
pollen(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen ex1, Animal
proteins(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen mx1,
Moulds(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen hx2, House
dust(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f27, Beef(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f31,
Carrot(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f35,
Potato(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f36,
Coconut(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f37, Blue
mussel(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f40,
Tuna(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f41, Salmon(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f44,
Strawberry(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f45,
Yeast(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f47,
Garlic(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f48,
Onion(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f49,
Apple(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen i6, Cockroach,
German(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen t20,
Mesquite(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen d3, House dust
mite(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen w20, Nettle(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen fx5,
Food(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f79, Gluten(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f80,
Lobster(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f81, Cheese,
cheddar type(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f87,
Melon(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f88,
Mutton(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen e82, Rabbit
epithelium(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen i71,
Mosquito(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f214,
Spinach(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f254,
Plaice(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c5,
Ampicilloyl(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c6,
Amoxicilloyl(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen k82,
Latex(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f256,
Walnut(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f78, Allergen
component nBos d 8 Casein, Milk(ImmunoCAP)-ImmunoCAP Specific
IgE is an in vitro test system for the quantitative measurement of
allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f17, Hazel
nut(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen w1, Common ragweed(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f201, Pecan nut(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f259, Grape(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f210,
Pineapple(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f215,
Lettuce(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f216,
Cabbage(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f235,
Lentil(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f218, Paprika,
Sweet pepper(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f280, Black
pepper(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f284, Turkey
meat(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f245, Egg(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f208,
Lemon(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m207, Aspergillus
niger(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen e213, Parrot feathers(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f202, Cashew nut(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f203, Pistachio(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f244, Cucumber(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen fx15, Fruits(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen d201,
House dust mite(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m36, Aspergillus
terreus(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen mx4,
Moulds(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c8,
Chlorhexidine(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen w230, Allergen
component nAmb a 1 Ragweed(ImmunoCAP)-ImmunoCAP Specific
IgE is an in vitro test system for the quantitative measurement of
allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c260,
Morphine(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c261,
Pholcodine(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen i208, Allergen
component rApi m 1 Phospholipase A2, Honey bee(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen e215, Pigeon feathers(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f262, Aubergine, eggplant(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f269, Basil(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f287, Red
kidney bean(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,

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License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen rx2,
Regional(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f309, Chick
pea(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen rx3, Regional(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen fx21,
Fruits(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f315, Green
bean(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f316, Rape seed(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen m210, Trichophyton ment. var
goetzii(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Rare Allergen c209,
Chymopapain(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c202,
Suxamethonium (Succinylcholine)(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen i206,
Cockroach, American(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f342,
Olive(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen m227, Malassezia spp.(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen m228, Aspergillus flavus(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Phadiatop(ImmunoCAP)-ImmunoCAP Phadiatop
is an in vitro qualitative and semiquantitative assay for graded

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of IgE antibodies specific to inhalant allergens in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Phadiatop is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Phadiatop(ImmunoCAP)-Phadiatop is an in vitro
qualitative assay for the differential determination of IgE antibodies
specific to inhalant allergens in human serum and plasma. Phadiatop
is to be used in Phadia instrument system. It is intended for in vitro
diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is
intended for use in clinical laboratories, as well as, physician office
laboratories.,ImmunoCAP Phadiatop Infant(ImmunoCAP)-
ImmunoCAP Phadiatop Infant is an in vitro qualitative and
semiquantitative assay for graded determination of IgE antibodies, in
human serum or plasma, specific to allergens that are relevant in the
development of atopy in small children. It is intended for in vitro
diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Phadiatop Infant is to be
used with the instruments Phadia 100, Phadia 200, Phadia 250,
Phadia 1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g4,
Meadow fescue(ImmunoCAP )-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g5, Rye-
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g8, Meadow
grass, Kentucky blue(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g10, Johnson
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g13, Velvet
grass(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen h2, House dust
(Hollister-Stier Labs.)(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g6,
Timothy(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen g12, Cultivated
rye(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t3, Common silver birch(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen w6, Mugwort(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m2,
Cladosporium herbarum(ImmunoCAP)-ImmunoCAP Specific IgE is an
in vitro test system for the quantitative measurement of allergen
specific IgE in human serum or plasma. It is intended for in vitro

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m6,
Alternaria alternata(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen d1, House dust
mite(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen d2, House dust mite(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen e1, Cat dander(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen e5, Dog dander(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f1, Egg white(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f2,
Milk(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f4, Wheat(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f14,
Soybean(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen h1, House dust
(Greer Labs. Inc.)(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m3, Aspergillus
fumigatus(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m5, Candida
albicans(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen e3, Horse
dander(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f8, Maize,
Corn(ImmunoCAP )-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f13,
Peanut(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen w9, Plantain
(English), Ribwort(ImmunoCAP)-ImmunoCAP Specific IgE is an in
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c1, Penicilloyl
G(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system for
the quantitative measurement of allergen specific IgE in human serum
or plasma. It is intended for in vitro diagnostic use as an aid in the
clinical diagnosis of IgE mediated allergic disorders in conjunction with
other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen c2, Penicilloyl V(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen i1, Honey bee venom(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t2, Grey alder(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen t7,
Oak(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t9, Olive(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen t12,
Willow(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen w10, Goosefoot,
Lamb's quarters(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen m4, Mucor
racemosus(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f3, Fish (cod)
(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system for
the quantitative measurement of allergen specific IgE in human serum
or plasma. It is intended for in vitro diagnostic use as an aid in the
clinical diagnosis of IgE mediated allergic disorders in conjunction with
other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen m1, Penicillium
chrysogenum(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen e4, Cow
dander(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen e6, Guinea pig
epithelium(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen e85, Chicken
feathers(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f6,
Barley(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f7,
Oat(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t16, White pine(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t18, Eucalyptus, Gum-tree(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t21, Melaleuca, Cajeput-
tree(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
5000.,ImmunoCAP Allergen w11, Saltwort (prickly), Russian
thistle(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen w13,
Cocklebur(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen w14, Common
pigweed(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen tx7, Tree
pollen(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f84, Kiwi
fruit(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f85, Celery(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen t70,
Mulberry(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f89,
Mustard(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f91,
Mango(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f92,
Banana(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f93,
Cacao(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f94,
Pear(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen f95, Peach(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen c73, Insulin
human(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen k71, Castor
bean(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test system
for the quantitative measurement of allergen specific IgE in human
serum or plasma. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of IgE mediated allergic disorders in conjunction
with other clinical findings, and is to be used in clinical laboratories.
ImmunoCAP Specific IgE is to be used with the instruments Phadia
100, Phadia 200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen e71, Mouse epithelium(ImmunoCAP)-
ImmunoCAP Specific IgE is an in vitro test system for the quantitative
measurement of allergen specific IgE in human serum or plasma. It is
intended for in vitro diagnostic use as an aid in the clinical diagnosis of
IgE mediated allergic disorders in conjunction with other clinical
findings, and is to be used in clinical laboratories. ImmunoCAP
Specific IgE is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia
5000.,ImmunoCAP Allergen t8, Elm(ImmunoCAP)-ImmunoCAP
Specific IgE is an in vitro test system for the quantitative measurement
of allergen specific IgE in human serum or plasma. It is intended for in
vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated
allergic disorders in conjunction with other clinical findings, and is to
be used in clinical laboratories. ImmunoCAP Specific IgE is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen t14,
Cottonwood(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f291,
Cauliflower(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f268,
Clove(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f221,
Coffee(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f279,
Chilipepper(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f263, Green
pepper (unripe seed)(ImmunoCAP)-ImmunoCAP Specific IgE is an in

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
vitro test system for the quantitative measurement of allergen specific
IgE in human serum or plasma. It is intended for in vitro diagnostic
use as an aid in the clinical diagnosis of IgE mediated allergic
disorders in conjunction with other clinical findings, and is to be used
in clinical laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f212, Mushroom
(champignon)(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro
test system for the quantitative measurement of allergen specific IgE
in human serum or plasma. It is intended for in vitro diagnostic use as
an aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,ImmunoCAP Allergen f293,
Papaya(ImmunoCAP)-ImmunoCAP Specific IgE is an in vitro test
system for the quantitative measurement of allergen specific IgE in
human serum or plasma. It is intended for in vitro diagnostic use as an
aid in the clinical diagnosis of IgE mediated allergic disorders in
conjunction with other clinical findings, and is to be used in clinical
laboratories. ImmunoCAP Specific IgE is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,IgA/IgG Calibrator(ImmunoCAP)-
ImmunoCAP Specific IgG is an in vitro test system for the quantitative
measurement of specific IgG antibodies in human serum or plasma. It
is intended for in vitro diagnostic use in conjunction with other clinical
findings and is to be used in clinical laboratories. ImmunoCAP
Specific IgG is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.,Specific
IgG Sample Diluent(ImmunoCAP)-ImmunoCAP Specific IgG is an in
vitro test system for the quantitative measurement of specific IgG
antibodies in human serum or plasma. It is intended for in vitro
diagnostic use in conjunction with other clinical findings and is to be
used in clinical laboratories. ImmunoCAP Specific IgG is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
1000, Phadia 2500 or Phadia 5000.,Antigen Ge91 Pigeon serum
proteins, features and droppings(ImmunoCAP)-ImmunoCAP Specific
IgG is an in vitro test system for the quantitative measurement of
specific IgG antibodies in human serum or plasma. It is intended for in
vitro diagnostic use in conjunction with other clinical findings and is to
be used in clinical laboratories. ImmunoCAP Specific IgG is to be
used with the instruments Phadia 100, Phadia 200, Phadia 250,
Phadia 1000, Phadia 2500 or Phadia 5000.,Antigen Gm24,
Stachybotrys atra(ImmunoCAP)-ImmunoCAP Specific IgG is an in
vitro test system for the quantitative measurement of specific IgG
antibodies in human serum or plasma. It is intended for in vitro
diagnostic use in conjunction with other clinical findings and is to be
used in clinical laboratories. ImmunoCAP Specific IgG is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,Antigen Gm23,
Thermoactinomyces vulgaris(ImmunoCAP)-ImmunoCAP Specific IgG
is an in vitro test system for the quantitative measurement of specific
IgG antibodies in human serum or plasma. It is intended for in vitro
diagnostic use in conjunction with other clinical findings and is to be
used in clinical laboratories. ImmunoCAP Specific IgG is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,Antigen Gm22, Micropolyspora
faeni(ImmunoCAP)-ImmunoCAP Specific IgG is an in vitro test system
for the quantitative measurement of specific IgG antibodies in human
serum or plasma. It is intended for in vitro diagnostic use in
conjunction with other clinical findings and is to be used in clinical
laboratories. ImmunoCAP Specific IgG is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,Antigen Ge92, Parrot serum proteins,
feathers and droppings(ImmunoCAP)-ImmunoCAP Specific IgG is an
in vitro test system for the quantitative measurement of specific IgG
antibodies in human serum or plasma. It is intended for in vitro
diagnostic use in conjunction with other clinical findings and is to be
used in clinical laboratories. ImmunoCAP Specific IgG is to be used
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
1000, Phadia 2500 or Phadia 5000.,Antigen Gmx6,
Moulds(ImmunoCAP)-ImmunoCAP Specific IgG is an in vitro test
system for the quantitative measurement of specific IgG antibodies in
human serum or plasma. It is intended for in vitro diagnostic use in
conjunction with other clinical findings and is to be used in clinical
laboratories. ImmunoCAP Specific IgG is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,Specific IgA/IgG Sample
Diluent(ImmunoCAP)-ImmunoCAP Specific IgG is an in vitro test
system for the quantitative measurement of specific IgG antibodies in
human serum or plasma. It is intended for in vitro diagnostic use in
conjunction with other clinical findings and is to be used in clinical
laboratories. ImmunoCAP Specific IgG is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,Specific IgG m3 Control
H(ImmunoCAP)-ImmunoCAP Specific IgG/IgG4 Controls are used for
monitoring ImmunoCAP Specific IgG measurements performance in
Phadia instruments.,Specific IgG/IgG4 i1 Control H(ImmunoCAP)-
ImmunoCAP Specific IgG/IgG4 Controls are used for monitoring
ImmunoCAP Specific IgG measurements performance in Phadia
instruments.,Specific IgG/IgG4 Control L(ImmunoCAP)-ImmunoCAP
Specific IgG/IgG4 Controls are used for monitoring ImmunoCAP
Specific IgG measurements performance in Phadia
instruments.,Specific IgG Curve Control Strip(ImmunoCAP)-
ImmunoCAP Specific IgG is an in vitro test system for the quantitative
measurement of specific IgG antibodies in human serum or plasma. It
is intended for in vitro diagnostic use in conjunction with other clinical
findings and is to be used in clinical laboratories. ImmunoCAP
Specific IgG is to be used with the instruments Phadia 100, Phadia
200, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.,Specific
IgG Calibrator Strip(ImmunoCAP)-ImmunoCAP Specific IgG is an in
vitro test system for the quantitative measurement of specific IgG
antibodies in human serum or plasma. It is intended for in vitro
diagnostic use in conjunction with other clinical findings and is to be
used in clinical laboratories. ImmunoCAP Specific IgG is to be used

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
with the instruments Phadia 100, Phadia 200, Phadia 250, Phadia
1000, Phadia 2500 or Phadia 5000.,Specific IgG Conjugate
50(ImmunoCAP)-ImmunoCAP Specific IgG is an in vitro test system
for the quantitative measurement of specific IgG antibodies in human
serum or plasma. It is intended for in vitro diagnostic use in
conjunction with other clinical findings and is to be used in clinical
laboratories. ImmunoCAP Specific IgG is to be used with the
instruments Phadia 100, Phadia 200, Phadia 250, Phadia 1000,
Phadia 2500 or Phadia 5000.,Maintenance Solution Kit(NIL)-
Maintenance Solution Kit is intended for cleaning of Phadia™
instruments.

654 IMP/IVD/2019/000475 Thermo Fisher EliA CCP Well( EliA™ )-"EliA CCP is intended for the in vitro CDSCO Class C
Scientific India quantitative measurement of IgG antibodies directed to CCP in human
Pvt. Ltd. serum and plasma. The presence of anti-CCP antibodies can be used
in conjunction with clinical findings and other laboratory tests as an aid
in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses
the the EliA IgG method on the Phadia instruments."

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

655 IMP/IVD/2019/000477 DIATEK Reaction Module(Maglumi)-Reaction Modules required for the CDSCO Class A
HEALTHCARE implementation of the MAGLUMI assays on the MAGLUMI series
PVT LTD Fully-auto chemiluminescence immunoassay analyzer.,System Tubing
Cleaning Solution(Maglumi)-The MAGLUMI System Tubing Cleaning
Solution is used to clean the pipettor and the washer needles. It is
useful to minimize reagent carryover by reducing protein precipitation
in the tubing, and improve routine maintenance of the MAGLUMI
system. The kit can only be used with MAGLUMI Fully-auto
chemiluminescence immunoassay (CLIA) analyzer, with tubing
cleaning program.,Light Check(Maglumi)-Light Check reagent
required to check the validity of Starter 1+2 as well as the functioning
of the measuring and pipetting units. A Light Check has to be carried
out on the MAGLUMI series Fully-auto chemiluminescence
immunoassay analyzer either once daily prior to starting the first
measurement or whenever a new lot of starter reagents is used. This
control program checks the proper functioning of the instrument and
starter reagents to avoid data error due to instrument defects or
mislocated or expired starter reagents.,Starter 1+2(Maglumi)-Starter
reagent kit required to generate the chemiluminometric light signal
necessary for the implementation of MAGLUMI assays on the
MAGLUMI Fully-auto chemiluminescence immunoassay (CLIA)
analyzer.,Wash Concentrate(Maglumi)-MAGLUMI Wash Concentrate
is intended to be diluted for preparation of System Liquid which is
required for washing the magnetic mircobeads of the MAGLUMI Fully-
auto chemiluminescence immunoassay (CLIA) analyzer

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

656 IMP/IVD/2019/000477 DIATEK Myoglobin (CLIA)(Maglumi)-Intended use: The kit is an in vitro CDSCO Class B
HEALTHCARE chemiluminescence immunoassay for the quantitative determination
PVT LTD of Myoglobin in human serum,Ferritin (CLIA)(Maglumi)-The kit is an in
vitro chemiluminescence immunoassay for the quantitative
determination of Ferritin in human serum.,Cortisol (CLIA)(Maglumi
Cortisol (CLIA))-The kit is an in vitro chemiluminescence
immunoassay for the quantitative determination of Cortisol in human
serum.,25-OH Vitamin D (CLIA)(Maglumi 25-OH Vitamin D (CLIA))-
The kit is an in vitro chemiluminescence immunoassay for the
quantitative determination of 25-OH Vitamin D,17 OH-Progesterone
(CLIA)(Maglumi 17 OH-Progesterone (CLIA))-The kit is an
chemiluminescence immunoassay for the quantitative determination
of 17 OH-Progesterone in human serum.,Anti-TPO (CLIA)(Maglumi)-
The kit is an in vitro chemiluminescence immunoassay for the
quantitative determination of Anti TPO in human serum.,PCT (CLIA)
(Maglumi)-The kit is an in vitro chemiluminescence immunoassay for
the quantitative determination of PCT (Procalcitonin) in human
serum.,CK-MB (CLIA)(Maglumi)-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of CK-MB in human serum.,FT4 (CLIA)(Maglumi FT4 (CLIA))-The kit
is in vitro chemiluminescence immunoassay for quantitative
determination free thyroxine in human serum.,T3(CLIA)(Maglumi
T3(CLIA))-The kit is an in vitro chemiluminescence immunoassay for
the quantitative determination of triiodothyronine (T3) in human
serum.,FT3 (CLIA)(Maglumi FT3 (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of free triiodothyronine (FT3) in human serum.,T4 (CLIA)(Maglumi T4
(CLIA))-The kit is an in vitro chemiluminescence immuno assay for the
determination of thyroxine (T4) in human serum.,TSH (CLIA)(Maglumi
TSH (CLIA))-The kit is an in vitro chemiluminescence immunoassay
for the quantitative determination of TSH in human serum.,LH (CLIA)
(Maglumi LH (CLIA))-The kit is an in vitro chemiluminescence
immunoassay for the quantitative determination of LH in human
serum,Testosterone (CLIA)(Maglumi Testosterone (CLIA))-The kit is
an in vitro chemiluminescence immunoassay for the quantitative
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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of Testosterone in human serum.,PRL (CLIA)(Maglumi
PRL (CLIA))-The kit is an in vitro chemiluminescence immunoassay
for the quantitative determination of Prolactin in human serum.,FSH
(CLIA)(Maglumi FSH (CLIA))-The kit is an in vitro chemiluminescence
immunoassay for the quantitative determination of FSH in human
serum.,C-Peptide (CLIA)(Maglumi C-Peptide (CLIA))-The kit is in vitro
chemiluminescence immunoassay for the quantitative determination
of C-Peptide in human serum.,free Estriol (CLIA)(Maglumi free Estriol
(CLIA))-The kit is an in vitro chemiluminescence immunoassay for the
quantitative determination of free Estriol in human serum.,GH (CLIA)
(Maglumi GH (CLIA))-The kit is an in vitro chemiluminescence
immunoassay for the quantitative determination of growth hormone
(GH) in human serum.,Insulin (CLIA)(Maglumi Insulin (CLIA))-The kit
is an in vitro chemiluminescence immunoassay for the quantitative
determination of insulin in human serum.,free Testosterone (CLIA)
(Maglumi free Testosterone (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of free Testosterone in human serum.,HCG/Beta HCG (CLIA)
(Maglumi HCG/Beta HCG (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of human chorionic gonadotropin (Beta sub unit ) in human
serum.,GAD 65 (CLIA)(MAglumi GAD 65 (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of Glutamic acid decarboxylase antibody (GAD 65 ) in human
serum.,FA (CLIA)(Maglumi FA (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of Folic Acid (FA) in human serum.,Estradiol (CLIA)(Maglumi Estradiol
(CLIA))-The kit is an in vitro chemiluminescence immunoassay for the
quantitative determination of Estradiol in human serum. ,PRG (CLIA)
(Maglumi PRG (CLIA))-The kit is an in vitro chemiluminescence
immunoassay for the quantitative determination of Progesterone in
human serum.,Albumin (CLIA)(Maliumi Albumin (CLIA))-The kit is an
chemiluminescence immunoassay for the quantitative determination
of Albumin in human serum.,Intact PTH (CLIA)(Maglumi)-The kit is an
in vitro chemiluminescence immunoassay for the quantitative

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of Intact Parathyroid hormone (Intact PTH) in human
serum,AMH (CLIA)(Maglumi AMH (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of Anti Mullerian Hormone (AMH) in human serum.,Vitamin B 12
(CLIA)(Maglumi Vitamin B 12 (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of Vitamin 12 in human serum.,DHEA-S (CLIA)(Maglumi DHEA-S
(CLIA))-The kit is an in vitro chemiluminescence immunoassay for the
quantitative determination of dehydroepiandrosterone (DHEA-S) in
human serum.,IgE (CLIA)(Maglumi IgE (CLIA))-The kit is an in vitro
chemiluminescence immunoassay for the quantitative determination
of IgE in human serum.

657 IMP/IVD/2019/000478 Trivitron ThinPrep Nuclear Stain Solution (ThinPrep Nuclear Stain Solution )- CDSCO Class A
Healthcare Pvt. ThinPrep Nuclear Stain is intended to be used in a Papanicolaou
Ltd. staining procedure in conjunction with ThinPrep Rinse Solution,
ThinPrep Bluing Solution, ThinPrep Orange G Solution, and ThinPrep
EA Solution.,ThinPrep Rinse Solution(ThinPrep Rinse Solution)-
ThinPrep Rinse Solution is intended to be used in a Papanicolaou
staining procedure in conjunction with ThinPrep Nuclear Stain,
ThinPrep Bluing Solution, ThinPrep Orange G Solution, and ThinPrep
EA Solution.,ThinPrep Orange G Solution(ThinPrep Orange G
Solution)-ThinPrep Orange G Solution is intended to be used in a
Papanicolaou staining procedure in conjunction with ThinPrep Nuclear
Stain, ThinPrep Rinse Solution, ThinPrep Bluing Solution, and
ThinPrep EA Solution.,ThinPrep Bluing Solution (ThinPrep Bluing
Solution )-ThinPrep Bluing Solution is intended to be used in a
Papanicolaou staining procedure in conjunction with ThinPrep Nuclear
Stain, ThinPrep Rinse Solution, ThinPrep Orange G Solution, and
ThinPrep EA Solution. ,ThinPrep EA Solution (ThinPrep EA Solution )-
ThinPrep EA Solution is intended to be used in a Papanicolaou
staining procedure in conjunction with ThinPrep Nuclear Stain,
ThinPrep Rinse Solution, ThinPrep Bluing Solution, and ThinPrep
Orange G Solution.

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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

658 IMP/IVD/2019/000478 Trivitron ThinPrep Pap Test PreservCyt Solution(ThinPrep Pap Test PreservCyt CDSCO Class B
Healthcare Pvt. Solution)-It is designed for use with the ThinPrep® processors.
Ltd. PreservCyt Solution is a methanol-based reagent that serves as a
transport, preservative, and antibacterial medium for gynecologic
samples.,ThinPrep PreservCyt Solution(ThinPrep PreservCyt
Solution)-PreservCyt® Solution is designed for use with the
ThinPrep® processor. PreservCyt Solution is a methanol-based
transport medium and preservative for cytologic samples.,ThinPrep
CytoLyt Solution(ThinPrep CytoLyt Solution)-CytoLyt® Solution is a
water-based, buffered cell wash solution designed to lyse red blood
cells, prevent protein precipitation, dissolve mucus, and preserve
morphology of general cytology cellular samples prior to slide
preparation with a ThinPrep® processor.

659 IMP/IVD/2019/000479 GASTROLAB ScheBo Pancreatic Elastase 1 ELISA Stool Test(NA)-Quantitative CDSCO Class B
INDIA PVT. LTD. ELISA test based on monoclonal antibodies. To measure Elastase 1 in
stool for the diagnosis/exclusion of an exocrine pancreatic
insufficiency.,ScheBo Pancreatic Elastase 1 Quick(NA)-Quantitative
Rapid test based on monoclonal antibodies. To measure Elastase 1 in
stool for the diagnosis/exclusion of an exocrine pancreatic
insufficiency.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

660 IMP/IVD/2019/000480 Weldon Biotech ichroma™ Cortisol(ichroma™ Cortisol)-ichroma™ Cortisol is a CDSCO Class B
India Pvt. Ltd fluorescence Immunoassay (FIA) for the quantitative determination of
Cortisol in human whole blood/serum/ plasma. It is useful as an aid in
management and monitoring of concentration of cortisol.,ichroma™
Microalbumin(ichroma™ Microalbumin)-ichroma™ Microalbumin is a
fluorescence Immunoassay (FIA) for the quantitative determination of
Microalbumin in human urine. It is useful as an aid in management
and monitoring of determination of kidney damage from
diabetes.,ichroma™ Myoglobin(ichroma™ Myoglobin)-ichroma™
Myoglobin is a fluorescence Immunoassay (FIA) for the quantitative
determination of Myoglobin in human whole blood/ serum/plasma. It is
useful as an aid in management and monitoring of acute myocardial
infarction (AMI).,ichroma™ D-Dimer(ichroma™ D-Dimer)-ichroma™
D-Dimer is a fluorescence Immunoassay (FIA) for the quantitative
determination of D-Dimer in human whole blood / plasma. It is useful
as an aid in management and monitoring of post therapeutic
evaluation of thromboembolic disease patients.,ichroma™ CK-
MB(ichroma™ CK-MB)-ichroma™ CK-MB is a fluorescence
Immunoassay (FIA) for the quantitative determination of Creatine
Kinase Isoenzyme-MB (CK-MB) in human whole blood/serum/plasma.
It is useful as an aid in management and monitoring of acute
myocardiac infarction (AMI) and acute coronary syndrome
(ACS).,ichroma™ ASO(ichroma™ ASO)-ichroma™ ASO is a
fluorescence Immunoassay (FIA) for the quantitative determination of
Anti Streptolysin O (ASO) in human serum/plasma. It is useful as an
aid in management and monitoring of scarlet fever, rheumatic fever
and post infectious glomerulonephritis along with several other
conditions.,ichroma™ PCT Plus(ichroma™ PCT Plus)-ichroma™ PCT
Plus is a fluorescence Immunoassay (FIA) for the quantitative
determination of Procalcitonin (PCT) in human whole
blood/serum/plasma. It is useful as an aid in management and
monitoring of bacterial infection and sepsis.,ichroma™
PCT(ichroma™ PCT)-ichroma™ PCT is a fluorescence Immunoassay
(FIA) for the quantitative determination of Procalcitonin (PCT) in
human whole blood/serum/plasma. It is useful as an aid in
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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
management and monitoring of bacterial infection and
sepsis.,ichroma™ CRP(ichroma™ CRP)-ichroma™ CRP is a
fluorescence Immunoassay (FIA) for the quantitative determination of
CRP in human whole blood/serum/ plasma. It is useful as an aid in
management and monitoring of autoimmune diseases and infectious
processes, such as rheumatoid arthritis,ichroma™ TSH(ichroma™
TSH)-ichroma™ TSH is a fluorescence Immunoassay (FIA) for the
quantitative determination of TSH in human serum/plasma. It is useful
as an aid in management and monitoring of measurement in the
assessment of thyroid function.,ichroma™ Testosterone(ichroma™
Testosterone)-ichroma™ Testosterone is a fluorescence
Immunoassay (FIA) for the quantitative determination of Testosterone
in human serum/plasma. It is useful as an aid in management and
monitoring of androgen level.,ichroma™ Anti-CCP(ichroma™ Anti-
CCP)-ichroma™ Anti-CCP is a fluorescence Immunoassay (FIA) for
the qualitative or semi-quantitative determination of human IgG
autoantibodies to cyclic citrullinated peptides (CCP) in human whole
blood/serum/plasma. It is useful as an aid in the diagnosis of
rheumatoid arthritis (RA) in combination with other clinical and
laboratory findings.,ichroma™ Vitamin D(ichroma™ Vitamin D)-
ichroma™ Vitamin D is a fluorescence Immunoassay (FIA) for the
quantitative determination of total 25(OH)D2/D3 level in regulating the
concentration of calcium and phosphate in the bloodstream and
promoting the healthy growth and remodeling of bone. human
serum/plasma. It is useful as an aid in management and monitoring of
bone,ichroma™ Ferritin(ichroma™ Ferritin)-ichroma™ Ferritin is a
fluorescence Immunoassay (FIA) for the quantitative determination of
Ferritin in human serum/plasma. It is useful as an aid in quantifies
human ferritin,ichroma™RF IgM(ichroma™RF IgM)-
ichroma™RFIgMis a fluorescence Immunoassay (FIA) for the
quantitative determination of RF IgMinhumanwhole blood/serum/
plasma.It is useful as an aid in management and monitoring of
rheumatoid arthritis.,ichroma™ Progesterone(ichroma™
Progesterone)-ichroma™ Progesterone is a fluorescence
Immunoassay (FIA) for the quantitative determination of progesterone

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License
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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
in human serum/plasma. It is useful as an aid in management and
monitoring of the cause of infertility, track ovulation, diagnose an
ectopic or failing pregnancy, monitor the health of a
pregnancy.,ichroma™ FSH(ichroma™ FSH)-ichroma™ FSH is a
fluorescence Immunoassay (FIA) for the quantitative determination of
follicle stimulating hormone(FSH) in human serum/ plasma. It is useful
as an aid in management and monitoring of concentration of
FSH.,ichroma™ T3(ichroma™ T3)-ichroma™ T3 is a fluorescence
Immunoassay (FIA) for the quantitative determination of
triiodothyronine (total T3) in human serum/plasma. It is useful as an
aid in management and monitoring of determination of thyroid
disorders.,ichroma™ Tn-I (ichroma™ Tn-I)-ichroma™ Tn-I is a
Fluorescence Immunoassay (FIA) for the quantitative determination of
cardiac troponin-I (Tn-I) in human whole blood/serum/plasma. It is
useful as an aid in management and monitoring of acute myocardial
infarction (AMI).,ichroma™ HbA1c(ichroma™ HbA1c)-ichroma™
HbA1c is a fluorescence Immunoassay (FIA) for the quantitative
determination of HbA1c(Hemoglobin A1c) in human whole blood. It is
useful as an aid in management and monitoring of the long-term
glycemic status in patients with diabetes mellitus,ichroma™
T4(ichroma™ T4)-ichroma™ T4 is a fluorescence Immunoassay (FIA)
for the quantitative determination of thyroxine (T4) in human
serum/plasma. It is useful as an aid in management and monitoring of
thyroid disorder.,ichroma™ β-HCG(ichroma™ β-HCG)-ichroma™ β-
HCG is a fluorescence Immunoassay (FIA) for the quantitative
determination of total β-hCG in human whole blood/serum/plasma. It
is useful as an aid in management and monitoring of total beta human
chorionic gonadotropin (total β-hCG) level in human.,ichroma™
LH(ichroma™ LH)-ichroma™ LH is a fluorescence Immunoassay
(FIA) for the quantitative determination of Luteinizing hormone (LH) in
human serum/plasma. It is useful as an aid in management and
monitoring of determination of evaluating fertility issues, function of
reproductive organs (ovaries or testicles), or detection of the
ovulation.,ichroma™ PRL(ichroma™ PRL)-ichroma™ PRL is a
fluorescence Immunoassay (FIA) for the quantitative determination of

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Prolactin (PRL) in human serum/plasma. It is useful as an aid in
management and monitoring of hypothalamic-pituitary
disorders.,Cardiac Triple(ichroma)-ichroma™ Cardiac Triple is a
Fluorescence Immunoassay (FIA) for the quantitative determination of
cardiac troponin‐I (Tn‐I), Creatine kinase (CK‐MB) and Myoglobin in
human whole blood/serum/plasma. It is useful as an aid in
management and monitoring of acute myocardial infarction (AMI) and
acute coronary syndrome (ACS). For in vitro diagnostic use only.
,AMH(ichroma)-ichroma™ AMH is a fluorescence Immunoassay (FIA)
for the quantitative determination of AMH (Anti-müllerian hormone) in
human serum/plasma. It is useful as an aid in management and
monitoring of premature ovarian insufficiency, menopause and ovarian
reserve. For in vitro diagnostic use only. ,ST2(ichroma)-ichroma™
ST2 is a fluorescence Immunoassay (FIA) for the quantitative soluble
Suppressor of Tumorigenicity 2 (ST2) level in human whole
blood/serum/plasma. It is useful as an aid in management and
assessing the prognosis of patients diagnosed with chronic heart
failure (CHF). For in vitro diagnostic use only. ,Dengue
IgG/IgM(ichroma)-ichroma™ Dengue IgG/IgM is a fluorescence
Immunoassay (FIA) for the qualitative determination of IgG/IgM
antibodies against dengue virus in human whole blood/serum/plasma.
It is useful as an aid in screening of Dengue virus infection. For in vitro
diagnostic use only. ,B-HCG(ichroma)-ichroma™ β-HCG is a
fluorescence Immunoassay (FIA) for the quantitative determination of
total β-hCG in human whole blood/serum/plasma. It is useful as an aid
in management and monitoring of total beta human chorionic
gonadotropin (total β-hCG) level in human. For in vitro diagnostic use
only. ,TSH PLUS(ichroma)-ichroma™ TSH Plus is a fluorescence
Immunoassay (FIA) for the quantitative determination of TSH in
human whole blood/serum/plasma. It is useful as an aid in
management and monitoring of measurement in the assessment of
thyroid function. For in vitro diagnostic use only. ,NT-Pro
BNP(ichroma)-ichroma™ NT-proBNP is a fluorescence Immunoassay
(FIA) for the quantitative determination of NT-proBNP in human whole
blood/ serum/plasma. It is useful as an aid in the diagnosis of persons

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
suspected of having congestive heart failure. For in vitro diagnostic
use only. ,Tn-I Plus(ichroma)-ichroma™ Tn I Plus is a Fluorescence
Immunoassay (FIA) for the quantitative determination of cardiac
troponin-I (Tn-I) in human whole blood/ serum/plasma It is useful as
an aid in management and monitoring of acute myocardial infarction
(AMI) For in vitro diagnostic use only. ,IL-6(ichroma)-ichroma™ IL-6 is
a fluorescence Immunoassay (FIA) for the quantitative detection of IL-
6 in human whole blood /serum/plasma. It is helpful as an aid in
management and monitoring of inflammatory disease. For in vitro
diagnostic use only. ,Anti-CCP PLUS(ichroma)-ichroma™ Anti-CCP
Plus is a fluorescence Immunoassay (FIA) for the qualitative or semi-
quantitative determination of human IgG autoantibodies to cyclic
citrullinated peptides (CCP) in human whole blood/serum/plasma. It is
useful as an aid in the diagnosis of rheumatoid arthritis (RA) in
combination with other clinical and laboratory findings. For in vitro
diagnostic use only. ,Calprotectin(ichroma)-ichroma™ Calprotectin is
a fluorescence Immunoassay (FIA) for quantitative determination of
Calprotectin (MRP8/14; S100A8/S100A9) in human feces. It is useful
as an aid in management and monitoring of the reflex gastrointestinal
inflammation caused by several pathologies (inflammatory bowel
disease, colorectal cancer and some enteropathies). For in vitro
diagnostic use only. ,Total IgE(ichroma)-ichroma™ Total IgE is a
fluorescence Immunoassay (FIA) for the quantitative determination of
total IgE in human whole blood/serum/plasma. It is useful as an aid in
diagnosis and management ofallegic disease. For in vitro diagnostic
use only.

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661 IMP/IVD/2019/000480 Weldon Biotech H.Pylori SA(ichroma)-ichroma™ H. pylori SA (H. pylori Stool Antigen) CDSCO Class C
India Pvt. Ltd is a fluorescence Immunoassay (FIA) for the qualitative determination
of H. pylori antigen in human feces. It is useful as an aid in the
diagnosis of H. pylori infection and to demonstrate loss of H. pylori
antigen following treatment. For in vitro diagnostic use only.,Dengue
NS1 Ag(ichroma)-ichroma™ Dengue NS1 Ag is a fluorescence
Immunoassay (FIA) for the qualitative determination of NS1 Antigen in
human whole blood/serum/plasma during dengue virus infection. It is
useful as an aid in screening of early Dengue virus infection. For in
vitro diagnostic use only.,COVID-19 Ag(ichroma)-ichroma™ COVID-
19 Ag is a fluorescence Immunoassay (FIA) for the qualitative
detection of novel corona virus (SARS-CoV-2, 2019-nCoV) in human
nasopharyngeal swab. It is helpful as an aid in the screening of early
mild, asymptomatic, or acute patients for identification of 'Novel
Coronavirus' infection. ,ichroma™ iFOB Neo(ichroma™ iFOB Neo)-
ichroma™ iFOBis a fluorescence Immunoassay (FIA) for the
quantitative determination of hemoglobin in human feces. It is useful
as an aid in management and monitoring of colorectal
cancer.,ichroma™ hsCRP(ichroma™ hsCRP)-ichroma™ hsCRP is a
fluorescence Immunoassay (FIA) for the quantitative determination of
CRP in human whole blood/serum/ plasma. It is useful as an aid in
management and monitoring of risk of cardiovascular
diseases.,ichroma™ PSA(ichroma™ PSA)-ichroma™ PSA is a
fluorescence Immunoassay (FIA) for the quantitative determination of
Prostate Specific Antigen (PSA) in human whole blood/serum/plasma.
It is useful as an aid in management and monitoring of prostate
cancer or other prostate disorders.,ichroma™ AFP(ichroma™ AFP)-
ichroma™AFP is a fluorescence Immunoassay (FIA) for the
quantitative determination of Alpha Feto Protein (AFP) in human
whole blood/serum/plasma. It is useful as an aid in management and
monitoring of primary hepatocellular carcinoma and non
seminomatous testicular cancer.,ichroma™ CEA(ichroma™ CEA)-
ichroma™ CEA is a fluorescence Immunoassay (FIA) for the
quantitative determination of CEA in human serum/plasma. It is useful
as an aid in management and monitoring of cancer
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patients.,ichroma™ Cystatin C(ichroma™ Cystatin C)-ichroma™
Cystatin C is a fluorescence Immunoassay (FIA) for the quantitative
determination of cystatin C in human serum/plasma. It is useful as an
aid in management and monitoring of renal disease.,COVID-19
Ab(ichroma)-Ichroma™ COVID-19 Ab is a fluorescence Immunoassay
(FIA) for the qualitative determination of IgG/IgM antibodies against
'Novel Coronavirus' in human whole blood / serum /plasma. It is
helpful as an aid in the screening of early mild, asymptomatic or acute
patients for identification of 'Novel Coronavirus (e.g., SARS-CoV-2)'
infection with high sensitivity.

662 IMP/IVD/2019/000481 DHR Holding Hemocue HbA1c 501 Monthly Check Cartridge(Hemocue HbA1c 501 CDSCO Class B
India Pvt. Ltd. Monthly Check Cartridge)-HemoCue HbA1c 501 check cartridge for
quality control which screens the optical and operation system of
analyzer ,Hemocue HbA1c 501 Daily Check Cartridge(Hemocue
HbA1c 501 Daily Check Cartridge)-HemoCue HbA1c 501 check
cartridge for quality control which screens the optical and operation
system of analyzer ,Hemocue HbA1c 501 Test Cartridge(Hemocue
HbA1c 501 Test Cartridge)-The HemoCue® HbA1c 501 Test
Cartridge, together with the HemoCue® HbA1c 501 Analyzer, which
are parts of the HemoCue® HbA1c 501 System provides a convenient
method for measuring hemoglobin A1c (HbA1c %) in both capillary
and anticoagulated venous whole blood samples. The test is used for
monitoring glycemic control in patients with diabetes mellitus and as a
supplement of the clinical evidence in the diagnosis of diabetes as
well as in identifying patients at risk for developing diabetes.

663 IMP/IVD/2019/000482 M/s. Germon Blood Glucose Test Strips(GMate)-The Gmate® Blood Glucose Test CDSCO Class B
Steels Global Pvt Strip is intended to be used for the quantitative measurement of
Ltd glucose in fresh capillary whole blood. The Gmate® Blood Glucose
Test Strip is intended for self-testing use outside the body (for in vitro
diagnostic use) by people with diabetes at home or by health
professionals in a clinical setting as an aid to monitor the effectiveness
of diabetes control.

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664 IMP/IVD/2019/000483 Bio-Rad Autoimmune EIA Anti Gliadin IgA Test(Autoimmune EIA Anti Gliadin CDSCO Class B
Laboratories IgA Test)-The Bio-Rad Autoimmune EIA Anti-Gliadin IgA Test is a solid
(India) Private phase enzyme immunoassay for the semi-quantitative and qualitative
Limited detection of IgA antibodies against gliadin in human serum. The assay
is an aid in the diagnosis of celiac disease (gluten-sensitive
enteropathy) and should be used in conjunction with other serological
tests and clinical findings. For In Vitro Diagnostic Use,Autoimmune
EIA Anti Tissue Transglutaminase (tTG) IgA Test(Autoimmune EIA Anti
Tissue Transglutaminase (tTG) IgA Test)-The Bio-Rad Autoimmune
EIA Anti-Tissue Transglutaminase (tTG) IgA Test is a solid phase
enzyme immunoassay for the semi-quantitative and qualitative
detection of IgA antibodies against tissue transglutaminase (tTG) in
human serum. The assay is an aid in the diagnosis of celiac disease
(glutensensitive enteropathy) and should be used in conjunction with
other serological tests and clinical findings,Autoimmune EIA Anti
Gliadin IgG Test(Autoimmune EIA Anti Gliadin IgG Test)-The Bio-Rad
Autoimmune EIA Anti-Gliadin IgG Test is a solid phase enzyme
immunoassay for the semi-quantitative and qualitative detection of
IgG antibodies against gliadin in human serum. The assay is an aid in
the diagnosis of celiac disease (glutensensitive enteropathy) and
should be used in conjunction with other serological tests and clinical
findings. For In Vitro Diagnostic Use.,Autoimmune EIA Anti
Saccharomyces Cerevisiae Antibodies (ASCA) IgG Test(Autoimmune
EIA Anti Saccharomyces Cerevisiae Antibodies (ASCA) IgG Test)-The
Bio-Rad Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies
(ASCA) IgG Test is a solid phase enzyme immunoassay (ELISA)
employing purified mannan for the semi-quantitative and qualitative
detection of IgG anti-Saccharomyces cerevisiae antibodies (ASCA) in
human serum. ASCA recognize specifically mannan, a component of
the outer cell wall of yeast.,Autoimmune EIA Anti Saccharomyces
Cerevisiae Antibodies (ASCA) IgA Test(Autoimmune EIA Anti
Saccharomyces Cerevisiae Antibodies (ASCA) IgA Test)-The Bio-Rad
Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA)
IgA Test is a solid phase enzyme immunoassay (ELISA) employing
purified mannan for the semi-quantitative and qualitative detection of
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IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human
serum. ASCA recognize specifically mannan, a component of the
outer cell wall of yeast. The Bio-Rad ASCA IgA Test Kit should not be
used as a screening test for ASCA, since some Crohn’s disease
patients do not have ASCA IgA antibodies. The Bio-Rad ASCA IgA
Test should be used to supplement, not replace, ASCA IgG testing.
The assay is an aid in the diagnosis of Crohn’s disease and should be
used in conjunction with other serological tests and clinical findings.
For In Vitro Diagnostic Use.,Autoimmune EIA Anti Tissue
Transglutaminase (tTG) IgG Test(Autoimmune EIA Anti Tissue
Transglutaminase (tTG) IgG Test)-The Bio-Rad Autoimmune EIA Anti-
Tissue Transglutaminase (tTG) IgG Test is a solid phase enzyme
immunoassay for the semi-quantitative and qualitative detection of
IgG antibodies against tissue transglutaminase (tTG) in human serum.
The assay is an aid in the diagnosis of celiac disease (glutensensitive
enteropathy) and should be used in conjunction with other serological
tests and clinical findings. For In Vitro Diagnostic Use.,Autoimmune
EIA AntiMyeloperoxidase (MPO) Test(Autoimmune EIA
AntiMyeloperoxidase (MPO) Test)-The Bio-Rad Autoimmune EIA Anti-
Myeloperoxidase (MPO) Test is a solid phase enzyme immunoassay
employing purified native myeloperoxidase (MPO) from human
peripheral blood polymorphonuclear cells for the semi-quantitative and
qualitative detection of antibodies against MPO in human serum. The
assay is an aid in the diagnosis of autoimmune systemic vasculitis,
such as microscopic polyangiitis and glomerulonephritis, and should
be used in conjunction with other laboratory and clinical findings
,Autoimmune EIA AntiProteinase 3 (PR3) Test(Autoimmune EIA
AntiProteinase 3 (PR3) Test)-The Bio-Rad Autoimmune EIA Anti-
Proteinase 3 (PR3) Test is a solid phase enzyme immunoassay
employing highly purified native human proteinase 3 (PR3) from
human neutrophil granulocytes for the semi-quantitative and
qualitative detection of antibodies against proteinase 3 in human
serum. The assay is an aid in the diagnosis of Wegener‘s
granulomatosis and should be used in conjunction with other
Laboratory and clinical findings.

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665 IMP/IVD/2019/000484 ACCUREX Immuno fluorescence Analyzer(Getein)-Getein1100 CDSCO Class A

BIOMEDICALS Immunofluorescence Quantitative Analyzer (hereinafter called
PVT. LTD. Getein1100) is an analyzer for processing and analysis of Getein test
kits including markers for cardiovascular diseases, renal diseases,
inflammation, fertility, diabetes mellitus, bone metabolism, tumor and
thyroid. This manual contains instructions for the use of Getein1100
and general instructions for testing specimens and quality control
materials.

666 IMP/IVD/2019/000484 ACCUREX HCG+Beta Fast Test Kit(Immuno fluorescence Assay)(GP)-Beta-hCG CDSCO Class B
BIOMEDICALS (β-hCG) is a test that measures the amount of human chorionic
PVT. LTD. gonadotropin (hCG) in the blood.,T3(T3Fast Test
Kit(Imumunofluorescence Assay))-Thyroid function Monitoring
,TSH(TSH Fast Test Kit (Imumunofluorescence Assay))-Thyroid
function Monitoring ,25-OH-VD(25-OH-VDFast Test Kit
(Imumunofluorescence Assay))-Bone turnover marker ,T4(T4 Fast
Test Kit(Imumunofluorescence Assay))-Thyroid function Monitoring
,Microalbuminuria (mAlb)(mAlb Fast Test Kit (Imumunofluorescence
Assay))-As an aid in the diagnosis of kidney diseases and increased
cardiovascular risk in diabetic nephropathy ,HbA1c(HbA1c Fast Test
Kit (Imumunofluorescence Assay))-Diabetes Monitoring ,IL-6 Fast Test
Kit (Immunofluorescence Assay)(GP)-IL-6 Fast Test Kit
(Immunofluorescence Assay) is intended for in vitroquantitative
determination of interleukin 6(IL-6) in human serum,plasma,whole
blood andperipheral blood samples. IL-6 is an early marker in acute
inflammation and this test can be used asan aid in the inflammatory
diseases.

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667 IMP/IVD/2019/000484 ACCUREX One step Test for Novel Coronavirus (2019- nCOV) IgM / IgG Antibody CDSCO Class C
BIOMEDICALS (Colloidal Gold )(Getein)-One Step Test for Novel Coronavirus (2019-
PVT. LTD. nCoV) IgM/IgG Antibody (Colloidal Gold) is intended for the qualitative
detection of 2019-Novel Coronavirus IgM and IgG antibody in serum,
plasma, fingertip blood or whole blood samples of pneumonitis
patients or suspected cases.,Cardiac Troponin I(Cardiac Troponin I
Fast Test Kit (Imumunofluorescence Assay))-As an aid in the
diagnosis of myocardial injury Unstable Angina, Acute Myocarditis and
Acute Myocardial Syndrome(ACS) ,D-Dimer(D-Dimer Fast Test Kit
(Imumunofluorescence Assay))-Rapid Screening for DVT & PE ,High
Sensitivity C-Reactive Protein (hs-CRP)(hs-CRP+CRP Fast Test Kit
(Imumunofluorescence Assay))-As an aid in the detection and
evaluation of infection, tissue injury and inflammatory disorders ,"N-
Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) "(NT-
proBNP Fast Test Kit (Imumunofluorescence Assay))-As an aid in the
clinical diagnosis, prognosis and evaluation of Heart Failure(HF)
,Creatine Kinase-MB/Cardiac Troponin I/Myoglobin(CK-MB/cTnI/Myo
Fast Test Kit (Imumunofluorescence Assay))-As an aid in the clinical
diagnosis, prognosis and evaluation of myocardial injury such as
Acute Myocardial Infarction(AMI), Unstable Angina, Acute Myocarditis
and Acute Myocardial Syndrome(ACS) ,Procalcitonin (PCT)(PCT Fast
Test Kit (Imumunofluorescence Assay))-As an aid in the assessment
and evaluation of patients suspected bacterial infection, trauma or
shock

668 IMP/IVD/2019/000485 Trivitron NS 2400(NA)-The NS2400 System is intended to be used as stand- CDSCO Class A
Healthcare Pvt. alone test automate for Labsystems Diagnostics neonatal kits in
Ltd screening laboratories by professional personnel.

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669 IMP/IVD/2019/000485 Trivitron Neonatal hTSH FEIA Plus(NA)-Labsystems Diagnostics’ Neonatal CDSCO Class C
Healthcare Pvt. hTSH FEIA Plus (fluorometric enzyme immunoassay) kit is for the
Ltd. quantitative determination of human thyrotropin (hTSH) in blood
samples dried on filter paper as a primary test for screening of babies
for congenital hypothyroidism (CH).,Neonatal IRT FEIA(NA)-
Labsystems Diagnostics’ Neonatal IRT FEIA (fluorometric enzyme
immunoassay) kit is for the quantitative determination of human
immunoreactive Trypsinogen (IRT) in blood samples dried on filter
paper as a primary test for screening of babies for cystic fibrosis
(CF).,NeoMass AAAC(NA)-Labsystems Diagnostics’ NeoMass AAAC
kit is for the quantitative measurement of amino acids, free carnitine
and acylcarnitines in blood samples dried on filter paper as a primary
test for screening of newborns for inborn errors of
metabolism.,NeoMass AAAC Plus(NA)-Labsystems Diagnostics’
NeoMass AAAC Plus kit is for the quantitative measurement of amino
acids, free carnitine, acylcarnitines, argininosuccinic acid and
succinylacetone in blood samples dried on filter paper as a primary
test for screening of newborns for inborn errors of
metabolism.,Neonatal Biotinidase(NA)-Neonatal Biotinidase kit is for
enzymatic determination of human Biotinidase enzyme activity from
blood samples dried on filter paper. Intended for newborn screening
for Biotinidase deficiency.,Neonatal Phenylalanine(NA)-Labsystems
Diagnostics’ Neonatal Phenylalanine' is designed for the quantitative
in vitro determination of phenylalanine concentration in blood
Specimens dried on filter paper intended for newborn screening for
phenylketonuria (PKU).,Neonatal GALT(NA)-Labsystems Diagnostics’
Neonatal GALT test is designed for the quantitative in vitro
determination of galactose-1-phosphate uridyltransferase (GALT)
activity in blood samples dried on filter paper intended for screening
newborns for classic galactosemia caused by galactose-1-phosphate
uridyltransferase deficiency.,Neonatal T4 FEIA(NA)-This Neonatal T4
FEIA kit is for the quantitative measurement of total Thyroxine
concentration in blood samples dried on filter paper as a primary test
for screening of babies for congenital hypothyroidism (CH).,Neonatal
17- OH Progesterone FEIA(NA)-Labsystems Diagnostics Neonatal
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17- OH Progesterone FEIA test is a simple competition fluorometric
enzyme immunoassay enabling the quantification of 17-
hydroxyprogestrone steroid present in blood samples dried on filter
paper.,Neonatal G6PD(NA)-Labsystems Diagnostics’ Neonatal G6PD
test is designed for the quantitative in vitro determination of glucose-6-
phosphate dehydrogenase activity in blood samples dried on filter
paper intended for newborn screening of glucose-6-phosphate
dehydrogenase deficiency.,Neonatal Galactose(NA)-Labsystems
Diagnostics’ Neonatal Galactose kit is intended for the quantitative
fluorometric determination of the total galactose from dried blood spot
samples. The test is based on the combined determination of free and
galactose liberated from the cleavage of the galactose-1-phosphate.

670 IMP/IVD/2019/000486 M/s.Roche Blood Glucose Test Strips(ACCU CHEK ACTIVE)-The Accu-Chek CDSCO Class B
Diabetes Care Active test strips are intended for quantitative blood glucose tests in
India Private fresh capillary blood. If the test strip is removed from the meter to
Limited apply blood, venous blood anticoagulated with lithium heparin or
ammonium heparin or EDTA, arterial blood and blood from neonates
may also be tested. The test strips may only be used together with
Accu Chek Active meters. The system comprises the meter and test
strips and is suitable for self-testing and for professional use. People
with diabetes can use this system to self-test their blood glucose.
Healthcare professionals can use this system to check patients’ blood
glucose values and they can use it in suspected cases of diabetes
and in emergency diagnostics. The system must not be used to
diagnose or rule out diabetes.

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671 IMP/IVD/2019/000487 Sysmex India CD4 easy count kit(CD4 easy count kit)-For in Vitro Diagnostic Use. CDSCO Class C
Pvt. Ltd. The CD4 easy count kit is a manual, two component, quantitative IVD
test for subpopulation labeling of lymphocytes in adult venous EDTA
whole blood, and subsequent enumeration with the Sysmex Partec
CyFlow Counter IVD flow cytometer. The CD4 cell concentration of
blood samples is a useful indicator for the initiation or follow-up of
treatment for HIV positive patients in conjunction with other laboratory
and Clinical findings The test is intended to be performed by trained
healthcare professionals..,CD4% easy count kit(CD4% easy count
kit)-The CD4% easy count kit is a manual, four-component,
quantitative IVD test for labelling of leukocytes and a subpopulation of
lymphocytes in adult venous EDTA whole blood, which can then be
enumerated with the Sysmex Partec CyFlow Counter IVD flow
cytometer. The CD4 T cell concentration and CD4% of lymphocytes in
blood samples are useful indicators for the initiation or follow-up of
treatment for HIV positive patients in conjuction with other laboratory
and clinical findings. The test is intended to be performed by trained
healthcare professionals.

672 IMP/IVD/2019/000488 BioSystems ISE Urine Diluent(DIESTRO)-Solution designed to dilute the urine CDSCO Class B
Diagnostics Pvt. when this will be used as a sample.,ISE Calibrating Kit(DIESTRO)-
Ltd. Used to calibrate and wash the ion-pH analyzer. Pack contains
solutions for two-point calibration.,Diestro Trilevel(DIESTRO)-It is
intended for use as a control material to monitor the measurement of
Na, K, Cl, Ca and Li.,ISE Calibrating Pack(DIESTRO)-Used to
calibrate and wash the ion-pH analyzer. Pack contains solutions for
two-point calibration.,ISE Cleaning Solution(DIESTRO)-Solution
designed to make the cleaning and decontamination of the
analyzer.,Sodium Conditioner(DIESTRO)-Solution designed to
conditioning the sodium electrode.

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673 IMP/IVD/2019/000489 Inbios India JE Detect™ IgM Elisa(JE Detect™ IgM ANTIBODY CAPTURE CDSCO Class B
ELISA)-The JE Detect™ IgM ELISA test for exposure to Japanese
Encephalitis Virus (JEV) is an ELISA assay system for the detection of
IgM antibodies in human serum to JEV-derived recombinant antigen
(JERA) (1-4).,Kalazar Detect™ Rapid Test(Inbios)-The Kalazar
Detect™ Test for Visceral Leishmaniasis (VL) is a rapid
immunochromatographic strip assay for the qualitative detection of
antibodies to members of L. donovani in human serum to aid in the
presumptive diagnosis of VL.,West Nile Detect IgM Capture
ELISA(Inbios)-The West Nile DetectTM IgM Capture ELISA is
designed for the qualitative detection of IgM antibodies to West Nile
recombinant antigens (WNRA) in human serum.,Scrub Typhus Detect
IgM Elisa(Inbios)-The Scrub Typhus Detect™ IgM ELISA test for
exposure to Orientia tsutsugamushi (OT; formerly Rickettsia) is an
ELISA assay system for the detection of IgM antibodies in human
serum to OT-derived recombinant antigen.

674 IMP/IVD/2019/000489 Inbios India DENV Detect NS1 ELISA(Inbios)-The DENV DetectTM NS1 ELISA is CDSCO Class C
for the early detection of Dengue virus (DENV) NS1 antigen in human
serum. This test is for the presumptive clinical laboratory diagnosis of
Dengue virus infection. This assay is intended for use in patients with
clinical symptoms consistent with either dengue fever or dengue
hemorrhagic fever.,SCoV-2 DetectTM IgG ELISA(Inbios)-The SCoV-2
Detect™ IgG ELISA is an in vitro diagnostic test for the qualitative
detection of IgG antibodies to SARS-CoV-2 in human serum.,SCoV-2
Detect IgM ELISA(Inbios)-The SCoV-2 Detect™ IgM ELISA is an in
vitro diagnostic test for the qualitative detection of IgM antibodies to
SARS-CoV-2 in human serum.

675 IMP/IVD/2019/000492 Beckman Coulter iQ Lamina (iQ Lamina )-iQ Lamina is intended for in vitro diagnostic CDSCO Class B
India Private use with iQ200 Series Analyzers
Limited Hisaria
Warehouse
Ground Floor

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676 IMP/IVD/2019/000494 LIFESCAN Control Solution (OneTouch Ultra)(OneTouch Ultra)-OneTouch® CDSCO Class C
MEDICAL Ultra™ Control Solution is used with OneTouch® Ultra™ Brand
DEVICES INDIA Systems, to check that the meter and test strips are working together
PRIVATE as a system and that you are performing the test correctly. It is very
LIMITED important that you do control solution tests routinely to make sure you
are getting accurate results.,Control Solution (OneTouch Select)
(OneTouch Select )-: For use with the OneTouch® SelectSimple™
Blood Glucose Meters to check that the meter and test strips are
working together properly and that you are performing the test
correctly.,Control Solutions (OneTouch Verio® )(OneTouch Verio®)-:
For use with the OneTouch Verio® Family of Blood Glucose Meters
(OneTouch Verio®, OneTouch Verio Flex™) and OneTouch Verio®
Test Strips to check that the meter and test strips are working together
properly and that you are doing the test correctly.,Control Solution
(OneTouch Select® Plus )(OneTouch Select®Plus)-For use with the
OneTouch Select® Plus Family of Blood Glucose Meters (OneTouch
Select Plus Simple®, OneTouch Select® Plus) and OneTouch Select®
Plus Test Strips to check that the meter and test strips are working
together properly and that the test is performing correctly.

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677 IMP/IVD/2019/000495 Thermo Fisher ApoA1/Apo B Calibrator(NA)-For in vitro diagnostic use only. Apo CDSCO Class B
Scientific India A1/Apo B Calibrator is used as a stock calibrator for quantification of
Pvt. Ltd. apolipoprotein A1 and B in serum and plasma by immunoturbidimetry
with Konelab™ and Indiko™ Clinical Chemistry Analyzers using the
Apolipoprotein A1 (code 981929) and Apolipoprotein B (code 981930)
methods defined by Thermo Fisher Scientific Oy. Any reference to the
Konelab systems also refers to the T Series ,HbA1c(NA)-For in vitro
diagnostic use in the quantitative determination of hemoglobin A1c
(HbA1c) in human whole blood on Konelab™and Indiko™analyzers.
The results are utilized in the long-term monitoring of glycemia. Any
reference to the Konelab™systems also refers to the T
Series.,Glucose (GOD-POD)(NA)-For in vitro diagnostic use in the
quantitative determination of glucose concentration in human serum
or plasma on Konelab and Indiko analyzers. Any reference to the
Konelab systems also refers to the T series.,HbA1c Pretreatment
Liquid(NA)-For in vitro diagnostic use in the determination of
hemoglobin A1c (HbA1c) on Konelab™and Indiko™analyzers. Any
reference to the Konelab systems also refers to the T
Series,Hemolyzing Reagent(NA)-For in vitro diagnostic use in the
determination of hemoglobin A1c (HbA1c) on Konelab™and
Indiko™analyzers. Any reference to the Konelab systems also refers
to the T Series,Apolipo-protein A1(NA)-For in vitro diagnostic use in
the quantitative determination of apolipoprotein A1 (Apo A1) in human
serum and plasma on Konelab and Indiko analyzers. Any reference to
the Konelab systems also refers to the T Series. ,Specical(NA)-
Specical is used as a stock calibrator for both quantification of specific
proteins in serum and plasma by immunoturbidimetry and for antigen
excess detection with Konelab™ and Indiko™ Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy. Any
reference to the Konelab systems also refers to the T Series
,Lipoprotein (a) Control(NA)-Lipoprotein(a) Control is intended for use
on Konelab™Clinical Chemistry Analyzers using methods defined by
Thermo Fisher Scientific Oy as a quality control to monitor precision of
the Lipoprotein(a) test. Any reference to the Konelab systems also
refers to the T Series. ,Lipoprotein (a) Control High(NA)-Lipoprotein(a)
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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Control High is intended for use on Konelab™ Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy as a
quality control to monitor precision of the Lipoprotein(a) test. Any
reference to the Konelab systems also refers to the T Series.
,Antistreptolysin O Calibrator(NA)-Antistreptolysin O Calibrator is used
as a stock calibrator for quantification of antistreptolysin O in serum
and plasma by immunoturbidimetry with Konelab™and
Indiko™Clinical Chemistry Analyzers using the Antistreptolysin O
(code 981802) method defined by Thermo Fisher Scientific Oy. Any
reference to the Konelab systems also refers to the T Series
,Complement C4(NA)-For in vitro diagnostic use in the quantitative
determination of complement C4 in human serum and plasma on
Thermo Scientific™Konelab™ and Indiko™ analyzers. Any reference
to the Konelab systems also refers to the T Series. ,Immunoglobulin A
(IgA)(NA)-For in vitro diagnostic use in the quantitative determination
of immunoglobulin A in human serum and plasma on Konelab and
Indiko analyzers. Any reference to the Konelab systems also refers to
the T Series. ,Antistreptolysin O(NA)-For in vitro diagnostic use in the
quantitative determination of antistreptolysin O (ASO) in human serum
on Konelab and Indiko analyzers. Any reference to the Konelab
systems also refers to the T-Series ,Immunoglobulin G (IgG)(NA)-For
in vitro diagnostic use in the quantitative determination of
immunoglobulin G in human serum and plasma on Konelab and
Indiko analyzers. Any reference to the Konelab systems also refers to
the T Series. ,Lipoprotein (a)(NA)-For in vitro diagnostic use in the
quantitative determination of Lipoprotein(a) in human serum, Li-
heparin plasma and EDTA plasma on Konelab™(20XT, 30, 60)
instruments. Any reference to the Konelab systems also refers to the
T series ,Immunoglobulin M (IgM)(NA)-For in vitro diagnostic use in
the quantitative determination of immunoglobulin M in human serum
and plasma on Konelab and Indiko analyzers. Any reference to the
Konelab systems also refers to the T Series. ,Lipoprotein (a)
Calibrator(NA)-Lipoprotein(a) Calibrator is used as a calibrator for
quantification of Lipoprotein(a) in serum and plasma by
immunoturbidimetry with Konelab™Clinical Chemistry Analyzers using

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
methods defined by Thermo Fisher Scientific Oy. Any reference to the
Konelab systems also refers to the T Series. ,Creatinine (Enzymatic)
(NA)-For in vitro diagnostic use in the quantitative determination of
creatinine concentration in human serum, plasma or urine on Konelab
and Indiko analyzers, using enzymatic method. Any reference to the
Konelab systems also refers to the T Series ,Rheumatoid Factors 2
(RF 2)(NA)-For in vitro diagnostic use in the quantitative determination
of rheumatoid factors in human serum and plasma on Thermo
Scientific™ Konelab™ and Indiko™ analyzers. Any reference to the
Konelab systems also refers to the T Series. ,Lipotrol HDL/LDL
Abnormal(NA)-Lipotrol HDL/LDL Abnormal is a control serum to
monitor trueness and precision of HDL-Cholesterol and LDL-
Cholesterol methods defined by Thermo Fisher- Scientific Oy on
Konelab and Indiko Clinical Chemistry Analyzers. ,Lipotrol(NA)-
Lipotrol is a control serum to monitor trueness and precision of lipid
and apolipoprotein methods defined by Thermo Fisher Scientific™ on
Indiko™ and Konelab™ Clinical Chemistry Analyzers. ,LDL-
Cholesterol(NA)-For in vitro diagnostic use in the quantitative
determination of LDL-cholesterol in human serum and plasma on
Thermo Scientific Indiko and Konelab analyzers. ,HDL-Cholesterol
Plus(NA)-For in vitro diagnostic use in the quantitative determination
of HDL-cholesterol in human serum and Li-heparin plasma on
Konelab and Indiko analyzers. Any reference to the Konelab systems
also refers to the T Series. ,Albumin MST(NA)-For in vitro diagnostic
use in the quantitative determination of albumin in human serum,
plasma and in low albumin concentration in urine (e.g.
microalbuminuria) on Konelab analyzer and in low albumin
concentration in urine (e.g. microalbuminuria) on Indiko analyzer. Any
reference to the Konelab systems also refers to the T series.
,Magnesium(NA)-For in vitro diagnostic use in the quantitative
determination of the magnesium concentration in human serum or
plasma on Thermo Scientific™ Indiko and Konelab analyzers. Any
reference to the Konelab systems also refers to the T Series. ,Albumin
BCG(NA)-For in vitro diagnostic use in the quantitative determination
of albumin in human serum or plasma on Konelab and Indiko

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
analyzers. Any reference to the Konelab systems also refers to the T
series. ,Acid Phosphatase(NA)-For in vitro diagnostic use in the
quantitative determination of total and nonprostatic (tartrate resistant)
acid phosphatase (EC 3.1.3.2; ACP) activity in human serum on
Konelab™ analyzers. Any reference to the Konelab systems also
refers to the T Series. ,Bilirubin Direct(NA)-For in vitro diagnostic use
in the quantitative determination of direct (conjugated) bilirubin
concentration in human serum or plasma on Thermo Scientific™
Indiko and Konelab analyzers. Any reference to the Konelab systems
also refers to the T Series. ,Bilirubin Total (NBD)(NA)-For in vitro
diagnostic use in the quantitative determination of total bilirubin in
human serum or plasma on Konelab and Indiko analyzers. Any
reference to Konelab systems also refers to the T Series.
,Bicarbonate(NA)-For in vitro diagnostic use in the quantitative
determination of bicarbonate (CO2) concentration in human serum or
plasma on Thermo Scientific™ Indiko™ and Konelab™ analyzers.
Any reference to the Konelab systems also refers to the T Series. ,CK-
MB Control(NA)-CK-MBControl is intended for use as a CK-MB and
CK precision control on Konelab™and Indiko™Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy. Any
reference to the Konelab systems also refers to the T Series. ,CK-
MB(NA)-For the in vitro quantitative determination of the B subunit of
the isoenzyme CK-MB of creatine kinase (ATP: Creatine N-
Phosphotransferase (CK), EC 2.7.3.2) activity in human serum or
plasma on Konelab and Indiko analyzers. Any reference to the
Konelab systems also refers to the T Series. ,Cholinesterase(NA)-For
in vitro diagnostic use in the quantitative determination of
cholinesterase (EC 3.1.1.8; SChE) activity in human serum or plasma
on Thermo Scientific™ Indiko™ and Konelab™ analyzers. Any
reference to the Konelab systems also refers to the T
Series.,Phosphorus(NA)-For in vitro diagnostic use in the quantitative
determination of the inorganic phosphate concentration in human
serum, plasma or urine on Konelab™and Indiko™analyzers. Any
reference to the Konelab systems also refers to the T Series
,Transferrin(NA)-For in vitro diagnostic use in the quantitative

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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
determination of transferrin in human serum and plasma on Konelab
and Indiko analyzers. Any reference to the Konelab systems also
refers to the T Series. ,sTfR Control(NA)-sTfR Control is intended for
use as an assayed control preparation to monitor trueness of soluble
transferrin receptor (sTfR) test on Thermo Scientific™ Konelab™and
Indiko™ Clinical Chemistry Analyzers using methods defined by
Thermo Fisher Scientific Oy. Any reference to the Konelab™systems
also refers to the T Series. ,Complement C3(NA)-For in vitro
diagnostic use in the quantitative determination of complement C3 in
human serum and plasma on Thermo Scientific™Konelab™ and
Indiko™ analyzers. Any reference to the Konelab systems also refers
to the T Series. ,sTfR Control High(NA)-sTfR Control High is intended
for use as an assayed control preparation to monitor trueness of
soluble transferrin receptor (sTfR) test on Thermo Scientific™
Konelab™and Indiko™ Clinical Chemistry Analyzers using methods
defined by Thermo Fisher Scientific Oy. Any reference to the
Konelab™systems also refers to the T Series. ,sTfR Calibration
Set(NA)-sTfR Calibration Set is used as a calibration set for
quantification of soluble transferrin receptor (sTfR) in serum and
plasma by immunoturbidimetry on Thermo Scientific™ Konelab™ and
Indiko™ Clinical Chemistry Analyzers using methods defined by
Thermo Fisher Scientific Oy. Any reference to the Konelab™systems
also refers to the T Series. ,sTfR(NA)-For in vitro diagnostic use in the
quantitative determination of the soluble transferrin receptor (sTfR)
concentration in human serum and plasma on Thermo Scientific™
Konelab™(60, 30, 20XT) and Indiko™ analyzers. Any reference to the
Konelab™systems also refers to the T Series. ,CRP Plus
Calibrator(NA)-CRP Plus Calibrator is used as a stock calibrator for
quantification of CRP in serum and plasma by immunoturbidimetry
with Konelab™ and Indiko™ Clinical Chemistry Analyzers using a
Thermo Fisher Scientific Oy defined method CRP Plus, code 981794
(Konelab), and code 981934 (Konelab and Indiko). ,CRP Plus(NA)-
For in vitro diagnostic use in the quantitative determination of CRP in
human serum and plasma on Konelab and Indiko analyzers. Any
reference to the Konelab systems also refers to the T Series.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
,Apolipoprotein B(NA)-For in vitro diagnostic use in the quantitative
determination of the apolipoprotein B (Apo B) in human serum and
plasma on Konelab and Indiko analyzers. Any reference to the
Konelab systems also refers to the T Series. ,Ferritin(NA)-For in vitro
diagnostic use in the quantitative determination of Ferritin
concentration in human serum and plasma on Konelab™(60, 30,
20XT) analyzers. Any reference to the Konelab systems also refers to
the T Series. ,Specitrol High(NIL)-Specitrol High is used as an
assayed control serum to monitor precision of specific protein tests on
Konelab™and Indiko™ Clinical Chemistry Analyzers using methods
defined by Thermo Fisher Scientific Oy.,uTrol High(NIL)-uTrol High is
intended for use on Konelab™and Indiko™ Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy as
an assayed control preparation to monitor precision of the analytes
listed in the analyzer specific value sheets.,uTrol(NIL)-uTrol is
intended for use on Konelab™and Indiko™Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy as
an assayed control preparation to monitor precision of the analytes
listed in the analyzer specific value sheets.,Specitrol(NIL)-Specitrol is
used as an assayed control serum to monitor precision of specific
protein tests defined by Thermo Fisher Scientific Oy on Konelab™
and Indiko™ Clinical Chemistry Analyzers.,sCal(NIL)-sCal is used as
a multicalibrator for substrate tests on Konelab™and Indiko™Clinical
Chemistry Analyzers using methods defined by Thermo Fisher
Scientific Oy.,Rheumatoid Factors Control(NIL)-Rheumatoid Factors
Control is intended for use on Thermo Scientific™ Konelab™and
Indiko™ Clinical Chemistry Analyzers as a quality control serum to
monitor the precision of Rheumatoid Factors test.,HbA1c
Calibrator(NIL)-For in vitro diagnostic use only. HbA1c Calibrator is
used as a stock calibrator for quantitation of HbA1c and Hb on
Konelab™and Indiko™Clinical Chemistry Analyzers using a Thermo
Fisher Scientific Oy defined method HbA1c (codes 981947 and
981948).,Ferritin Control High(NIL)-Ferritin Control High is intended
for use as an assayed control preparation to monitor trueness of
Ferritin test on Thermo Scientific™ Konelab™ and Indiko™ Clinical

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Chemistry Analyzers using methods defined by Thermo Fisher
Scientific Oy.,Ferritin Control(NIL)-Ferritin Control is intended for use
as an assayed control preparation to monitor trueness of Ferritin test
on Thermo Scientific™Konelab™and Indiko™ Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific
Oy.,Ferritin Calibration Set(NIL)-Ferritin Calibration Set is used as a
calibration set for quantification of ferritin in serum and plasma by
immunoturbidimetry on Thermo Scientific™ Konelab™and Indiko™
Clinical Chemistry Analyzers using methods defined by Thermo Fisher
Scientific Oy.,eCal(NIL)-eCal is used as a multicalibrator for enzyme
tests on Konelab™and Indiko™Clinical Chemistry Analyzers using
methods defined by Thermo Fisher Scientific Oy.,CRP High Sensitivity
Control(NIL)-CRP High Sensitivity Control is intended for use on
Thermo Scientific™ Konelab™and Indiko™Clinical Chemistry
Analyzers as a quality control serum to monitor precision of Thermo
Fisher Scientific Oy defined CRP High Sensitivity (981798) test.,CRP
Control High(NIL)-CRP Control High is intended for use on
Konelab™and Indiko™Clinical Chemistry Analyzers as a quality
control serum to monitor trueness of Thermo Fisher Scientific Oy
defined methods CRP (codes 981699 and 981933) and CRP Plus
(codes 981794 and 981934).,CRP Control(NIL)-CRP Control is
intended for use on Konelab™and Indiko™ Clinical Chemistry
Analyzers as a quality control serum to monitor trueness of Thermo
Fisher Scientific Oy defined methods CRP (codes 981699 and
981933) and CRP Plus (codes 981794 and 981934).,CRP Calibration
Set(NIL)-CRP Calibration Set is used as a calibration set for
quantification of CRP in serum and plasma by immunoturbidimetry
with Konelab™and Indiko™Clinical Chemistry Analyzers using a
Thermo Fisher Scientific Oy defined method CRP, code 981699
(Konelab), and code 981933 (Konelab and Indiko).,CK-MB Control
High(NIL)-CK-MB Control High is intended for use as a CK-MBand CK
precision control on Konelab™and Indiko™Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy.
,Albumin U Control High(NIL)-Albumin U Control High is intended for
use on Konelab™and Indiko™Clinical Chemistry Analyzers as a

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
quality control sample to monitor trueness of Thermo Fisher Scientific
Oy defined Albumin MST (code 981927) urine albumin method.
,Albumin U Control(NIL)-Albumin U Control is intended for use on
Konelab™and Indiko™Clinical Chemistry Analyzers as a quality
control sample to monitor trueness of Thermo Fisher Scientific Oy
defined Albumin MST (code 981927) urine albumin method. ,Albumin
U Calibrator(NIL)-Albumin U Calibrator is used as a stock calibrator
for quantification of albumin in urine by immunoturbidimetry with
Konelab™and Indiko™Clinical Chemistry Analyzers using Thermo
Fisher Scientific Oy defined method Albumin MST (code
981927).,Abtrol(NIL)-Abtrol is a control serum to monitor trueness and
precision of the analytes listed in the separate Abtrol value sheet. The
given values are valid for Konelab™and Indiko™Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy.,Uric
Acid (AOX)(NIL)-For in vitro use in the quantitative determination of
uric acid concentration in human serum, plasma or urine on Konelab
and Indiko analyzers.,Urea(NIL)-For in vitro diagnostic use in the
quantitative determination of urea concentration in human serum,
plasma or urine on Thermo Scientific™ Indiko™ and Konelab™
analyzers.,U/CSF Protein(NIL)-For the in vitro quantitative
determination of the total protein concentration in human urine and
cerebrospinal fluid on Thermo ScientificTM IndikoTM and KonelabTM
analyzers. All test results must be interpreted with regard to the
clinical context.,Nortrol(NIL)-Nortrol is a control serum to monitor
trueness and precision of the analytes listed in the separate Nortrol
value sheet. The given values are valid for Konelab™and
Indiko™Clinical Chemistry Analyzers using methods defined by
Thermo Fisher Scientific Oy.,HDL/LDL Calibrator(NIL)-For in vitro
diagnostic use only. HDL/LDL Calibrator is intended for the calibration
of HDL- and LDL-Cholesterol direct methods defined by Thermo
Fisher Scientific Oy on Konelab™ and Indiko™ Clinical Chemistry
Analyzers.,HbA1c Control Normal(NIL)-For in vitro diagnostic use
only. HbA1c Control Normal is intended for use on Konelab™and
Indiko™Clinical Chemistry Analyzers as a precision control sample for
the HbA1c test.,HbA1c Control Abnormal(NIL)-For in vitro diagnostic

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
use only. HbA1c Control Abnormal is intended for use on
Konelab™and Indiko™Clinical Chemistry Analyzers as a precision
control sample for the HbA1c test. ,Triglycerides(NIL)-For in vitro
diagnostic use in the quantitative determination of the triglycerides
concentration in human serum and plasma on Konelab and Indiko
analyzers.,Total Protein Plus(NIL)-For in vitro diagnostic use in the
quantitative determination of total protein concentration in human
serum or plasma on Konelab and Indiko analyzers.,Lipase
(Colorimetric)(NIL)-For in vitro diagnostic use in the quantitative
determination of the lipase (EC 3.1.1.3; triacylglycerol acylhydrolase)
concentration in human serum and human plasma on Thermo
Scientific™ Konelab™ and Indiko™ analyzers.,LDH (SCE)(NIL)-For in
vitro diagnostic use in the quantitative determination of LDH (L-
Lactate: NAD oxidoreductase EC 1.1.1.27) activity in human serum on
Thermo Scientific™ Indiko™ and Konelab™ analyzers.,LDH (IFCC)
(NIL)-For in vitro diagnostic use in the quantitative determination of
LDH (L-Lactate: NAD oxidoreductase EC 1.1.1.27) in human serum or
plasma on Thermo Scientific™ Indiko™ and Konelab™
analyzers.,Iron(NIL)-For in vitro diagnostic use in the quantitative
determination of the iron concentration in human serum or plasma on
Konelab and Indiko analyzers.,Glucose (HK)(NIL)-For in vitro
diagnostic use in the quantitative determination of the glucose
concentration in human serum, plasma or urine on Thermo
Scientific™ Indiko™ and Konelab™ analyzers.,Gamma-GT (IFCC)
(NIL)-For in vitro diagnostic use in the quantitative determination of
Gamma-GT ((γ-Glutamyl)-Peptide: Amino Acid γ-Glutamyltransferase
(GGT), EC 2.3.2.2) activity in human serum or plasma on Konelab
and Indiko analyzers.,CRP High Sensitivity(NIL)-For in vitro diagnostic
use in the quantitative determination of low concentrations of CRP in
human serum and plasma on Thermo Scientific™ Konelab™ and
Indiko™ analyzers.,CRP(NIL)-For in vitro diagnostic use in the
quantitative determination of CRP in human serum and plasma on
Konelab and Indiko analyzers.,Creatinine (Jaffé)(NIL)-For in vitro
diagnostic use in the quantitative determination of creatinine in human
serum, plasma or urine on Thermo Scientific™ Konelab™ and

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Indiko™ analyzers.,CK (IFCC)(NIL)-For in vitro diagnostic use in the
quantitative determination of creatine kinase (ATP: Creatine N-
Phosphotransferase (CK), EC 2.7.3.2) activity in human serum or
plasma on Thermo Scientific™ Indiko™and
Konelab™analyzers.,Cholesterol(NIL)-For in vitro diagnostic use in
the quantitative determination of cholesterol concentration in human
serum or plasma on Konelab and Indiko analyzers.,Calcium(NIL)-For
in vitro diagnostic use in the quantitative determination of the calcium
concentration in human serum, plasma or urine on Konelab and Indiko
analyzers.,AST/GOT (IFCC)(NIL)-For in vitro diagnostic use in the
quantitative determination of aspartate aminotransferase (LAspartate:
2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) activity in human
serum or plasma on Thermo Scientific™ Indiko™ and Konelab™
analyzers.,Amylase (IFCC) (NIL)-For in vitro diagnostic use in the
quantitative determination of α-amylase (1,4-α-D-glucan
glucanohydrolase, EC 3.2.1.1) activity in human serum, plasma or
urine on Thermo Scientific™ Indiko™ and Konelab™
analyzers.,ALT/GPT (IFCC)(NIL)-For in vitro diagnostic use in the
quantitative determination of alanine aminotransferase (L-Alanine: 2-
Oxoglutarate Aminotransferase (ALT), EC 2.6.1.2) activity in human
serum or plasma on Thermo Scientific™ Indiko™ and Konelab™
analyzers.,Alkaline Phosphatase (SCE)(NIL)-For the in vitro
quantitative determination of alkaline phosphatase (orthophosphoric -
monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity
in human serum or plasma on Konelab™analyzers according to SCE
method. All test results must be interpreted with regard to the clinical
context.,Alkaline Phosphatase (IFCC) Plus(NIL)-For in vitro diagnostic
use in the quantitative determination of alkaline phosphatase
(orthophosphoric - monoester phospho-hydrolase, alkaline optimum,
EC 3.1.3.1) activity in human serum or plasma on Thermo Scientific™
Indiko™ and Konelab™ analyzers according to the IFCC method
(1).,Albumin (BCP)(NIL)-For in vitro diagnostic use in the quantitative
determination of the albumin in human serum or plasma on Thermo
Scientific™ Konelab™ analyzers.

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

678 IMP/IVD/2019/000495 Thermo Fisher D-Dimer Calibration Set(NIL)-D-Dimer Calibration Set is used as a CDSCO Class C
Scientific India calibration set for quantification of D-Dimer in plasma by
Pvt. Ltd. immunoturbidimetry on Thermo Scientific™ Konelab™and Indiko™
Clinical Chemistry Analyzers using methods defined by Thermo Fisher
Scientific Oy.,D-Dimer(NIL)-For in vitro diagnostic use in the
quantitative determination of D-Dimer concentration in human plasma
on Thermo Scientific™ Konelab™(60, 30, 20XT) and Indiko™
analyzers. Any reference to the Konelab systems also refers to the T
Series.,D-Dimer Control High(NIL)-D-Dimer Control High is intended
for use as an assayed control preparation to monitor precision of D-
Dimer test on Thermo Scientific™ Konelab™and Indiko™ Clinical
Chemistry Analyzers using methods defined by Thermo Fisher
Scientific Oy.,D-Dimer Control(NIL)-D-Dimer Control is intended for
use as an assayed control preparation to monitor precision of D-Dimer
test on Thermo Scientific™ Konelab™and Indiko™ Clinical Chemistry
Analyzers using methods defined by Thermo Fisher Scientific Oy.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

679 IMP/IVD/2019/000496 B&E CellLyse(CellLyse)-It's used by Automated Hematology Analyzer as a CDSCO Class B
Diagnostics India Hemolyzing reagent for the Assay of White Blood Cell Count,
Pvt. Ltd. lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count,CellLyse(CellLyse)-
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell
Count,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count,CellLyse(CellLyse)-
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell
Count,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
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5/19/23, 5:58 PM MD - Medical Devices

License
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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
count, Eosinophil cell count, Neutrophil Cell Count,"Calibration Pack
for Electrolyte Analyzer"("Calibration Pack for Electrolyte Analyzer")-
for calibration of ion concentration, sodium, Potassium, chloride,
calcium, pH & TCO2 in different electrolyte analyzer,"Calibration Pack
for Electrolyte Analyzer"("Calibration Pack for Electrolyte Analyzer")-
for calibration of ion concentration, sodium, Potassium, chloride,
calcium, pH & TCO2 in different electrolyte analyzer,"Calibration Pack
for Electrolyte Analyzer"("Calibration Pack for Electrolyte Analyzer")-
for calibration of ion concentration, sodium, Potassium, chloride,
calcium, pH & TCO2 in different electrolyte analyzer,"Calibration Pack
for Electrolyte Analyzer"("Calibration Pack for Electrolyte Analyzer")-
for calibration of ion concentration, sodium, Potassium, chloride,
calcium, pH & TCO2 in different electrolyte
analyzer,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count,CellLyse(CellLyse)-
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell Count,"Hematology
Control"("Hematology Control")-to monitor the instrument
performance, also be available for Internal Quality Control and
External Quality Assessment.,"Calibration Pack for Electrolyte
Analyzer"("Calibration Pack for Electrolyte Analyzer")-for calibration of
ion concentration, sodium, Potassium, chloride, calcium, pH & TCO2
in different electrolyte analyzer,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count,CellLyse(CellLyse)-

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell
Count,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,"Hematology Control"("Hematology Control")-to
monitor the instrument performance, also be available for Internal
Quality Control and External Quality Assessment.,CellLyse(CellLyse)-
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell
Count,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count,CellLyse(CellLyse)-
It's used by Automated Hematology Analyzer as a Hemolyzing reagent
for the Assay of White Blood Cell Count, lymphocyte count, monocyte
cell count, Eosinophil cell count, Neutrophil Cell
Count,CellLyse(CellLyse)-It's used by Automated Hematology
Analyzer as a Hemolyzing reagent for the Assay of White Blood Cell
Count, lymphocyte count, monocyte cell count, Eosinophil cell count,
Neutrophil Cell Count,CellLyse(CellLyse)-It's used by Automated
Hematology Analyzer as a Hemolyzing reagent for the Assay of White
Blood Cell Count, lymphocyte count, monocyte cell count, Eosinophil
cell count, Neutrophil Cell Count,CellLyse(CellLyse)-It's used by
Automated Hematology Analyzer as a Hemolyzing reagent for the
Assay of White Blood Cell Count, lymphocyte count, monocyte cell
count, Eosinophil cell count, Neutrophil Cell Count

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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

680 IMP/IVD/2019/000497 Abbott FreeStyle Optium Blood Beta-Ketone Test Strips-Used for quantitative CDSCO Class B
Healthcare measurement of beta ketone (beta hydroxybutyrate) in fresh capillary
Private Limited blood samples,FreeStyle Optium H Blood Beta-Ketone Test Strips-
Used for quantitative measurement of beta ketone (beta
hydroxybutyrate) in fresh capillary and venous whole blood
samples,Freestyle Optium H Blood Glucose Test Strips-Used for
quantitative measurement of glucose (D glucose) in fresh capillary,
venous, arterial and neonatal whole blood samples,Freestyle Optium
Blood Glucose Test Strips-Used for quantitative measurement of
glucose (sugar) in fresh capillary blood samples

681 IMP/IVD/2019/000498 Abbott Alinity i STAT Myoglobin Controls(Alinity i STAT Myoglobin Controls)- CDSCO Class B
Healthcare Pvt. The Alinity i STAT Myoglobin Controls are for the verification of the
Ltd. accuracy and precision of the Alinity i analyzer when used for the
quantitative determination of myoglobin in human serum and
plasma.,Alinity i STAT CK-MB Controls(Alinity i STAT CK-MB
Controls)-The Alinity i STAT CK-MB Controls are for verification of the
accuracy and precision of the Alinity i analyzer when used for the
quantitative determination of CK-MB in human serum and plasma.

682 IMP/IVD/2019/000500 BIOLINE Hemoglobin Testing System(Mission Ultra)-To test Hemoglobin and CDSCO Class A
DIAGNOSTICS Hematocrit.,HA-360 3-Diff Automatic Hematology Analyzer(HA-360 3-
LLP Diff Automatic Hematology Analyzer)-To monitor the indicators in the
Blood.

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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

683 IMP/IVD/2019/000500 BIOLINE 3D Hematology Reagent (Cyto-Lyser)(3D Hematology Reagent (Cyto- CDSCO Class B
DIAGNOSTICS Lyser))-use in conjunction with HA-360 3-Diff Automatic Hematology
LLP Analyzer for blood cell analysis. ,3D Hematology Reagent (Mi-Po
Cleaner)(3D Hematology Reagent (Mi-Po Cleaner))-use in conjunction
with HA-360 3-Diff Automatic Hematology Analyzer for blood cell
analysis ,Ultra Hemoglobin Test Strips(Ultra Hemoglobin Test Strips)-
quantitative determination of Hemoglobin level in fresh fingertip
capillary or venous whole blood ,3D Hematology Reagent (Cyto-
Diluent)(3D Hematology Reagent (Cyto-Diluent))-use in conjunction
with HA-360 3-Diff Automatic Hematology Analyzer for blood cell
analysis. ,HB Hemoglobin Test Strips(HB Hemoglobin Test Strips)-The
Hb Hemoglobin Test Strips (Whole Blood) are firm plastic strips onto
which a multilayer dry reagent is affixed and are intended to be read
on the QUIK-CHECK® Hb Hemoglobin Meter. The test strips function
by lysing erythrocytes and converting the released hemoglobin into
methemoglobin. This test is for the quantitative determination of
hemoglobin (Hb) and calculated hematocrit (Hct) in capillary and
venous whole blood. The test strips are for professional use only.
,CHOL Total Cholesterol Test Strips(CHOL Total Cholesterol Test
Strips)-measure the Total Cholesterol concentration in whole blood.

684 IMP/IVD/2019/000500 BIOLINE PT/INR Test Strips(PT/INR Test Strips)-use with the PT/INR CDSCO Class C
DIAGNOSTICS Monitoring System to monitor blood clotting time in patients stabilized
LLP on Coumarin-type (e.g. warfarin) anticoagulation therapy.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

685 IMP/IVD/2020/000006 M/s. Peerless A1c HbA1c Analyzer(On Call A1c HbA1c Analyzer OGM-141)-The On CDSCO Class A
Biotech Pvt. Ltd. Call® A1c HbA1c Analyzer is intended for use in conjunction with the
On Call® A1c HbA1c Test Kit for measuring the Hemoglobin A1c
(HbA1c) ratio (percentage and mmol/mol) in capillary and venous
human whole blood.,U120 Smart Urine Analyzer(Mission U120 Smart
Urine Analyzer)-The Mission® U120 Smart Urine Analyzer is intended
for use in conjunction with the Mission® Urinalysis Reagent Strips for
the semi-quantitative detection of the following analytes in human
urine: Albumin, Creatinine, Glucose, Bilirubin, Ketone (Acetoacetic
acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes,
Ascorbic Acid and Calcium, as well as the qualitative detection of
Nitrite. The instrument is intended for professional, in vitro diagnostic
use only. The measurement can be used in general evaluation of
health, and aids in the diagnosis and monitoring of metabolic or
systemic diseases that affect kidney function, endocrine disorders and
diseases or disorders of the urinary tract. The Mission® U120 Smart
Urine Analyzer is intended for indoor use.,Biosensor Cholesterol
Starter Kit(QUIK-CHECK Ultra Biosensor Cholesterol Monitoring
System)-The QUIK-CHECK Ultra Cholesterol Monitoring System is
designed for the quantitative measurement of cholesterol level in fresh
fingertip capillary whole blood. It is intended for in vitro diagnostic use
and suitable for hypercholesterolemia management. For self-testing
and professional use.,Hb Hemoglobin Testing System(QUIK-CHECK
Plus Hb Hemoglobin Testing System)-The QUIK-CHECK Plus Hb
Hemoglobin Testing System is intended for the quantitative
determination of hemoglobin (Hb) and calculated hematocrit (Hct) in
capillary and venous human whole blood. The easy to operate system
consists of a portable meter that analyzes the intensity and color of
light reflected from the reagent area of a test strip, ensuring quick and
accurate results.,U500 Urine Analyzer(Mission U500 Urine Analyzer)-
The Mission® U500 Urine Analyzer is intended for use in conjunction
with the Mission® Urinalysis Reagent Strips for the semi-quantitative
detection of the following analytes in human urine: Glucose, Bilirubin,
Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein,
Urobilinogen, Leukocytes, Ascorbic Acid, Albumin, Creatinine, and
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5/19/23, 5:58 PM MD - Medical Devices

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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Calcium, as well as the qualitative detection of Nitrite. The instrument
is intended for professional, in vitro diagnostic use only.,HA-360 3-Diff
Automatic Hematology Analyzer(Mission HA-360 3-Diff Automatic
Hematology Analyzer)-The Mission® HA-360 3-Diff Automatic
Hematology Analyzer is intended for use in conjunction with the
Mission® 3D Hematology Reagents for human blood cell counting and
leukocyte differentiation in clinical laboratories. The analyzer is
intended for professional, in vitro diagnostic use only. The purpose of
this analyzer is to identify the normal patient, with all normal system-
generated parameters, and to flag or identify patient results that
require additional studies.

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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

686 IMP/IVD/2020/000006 M/s. Peerless Blood Ketone Test Strips(On Call)-To measure Ketone level in CDSCO Class B
Biotech Pvt. Ltd. blood,3D Hematology Reagent (Cyto-Diluent)(Mission)-Mission® 3D
Hematology Reagent (Cyto-Diluent) is intended for use in conjunction
with Mission® HA-360 3-Diff Automatic Hematology Analyzer for
human blood cell analysis. It is used to dilute and prepare the human
blood specimens for analysis.,Urinalysis Reagent Strips for 3
Parameter (Glucose, Protein and Ketone)(Mission)-To detect Glucose,
Protein and Ketone in Urine,Urinalysis Reagent Strips for 4 Parameter
(Glucose, Protein, pH and SG)(Mission)-To detect Glucose, Protein,
pH and SG in Urine,Urinalysis Reagent Strips for 10 Parameter
(Glucose, Protein, pH, Ketone, Leukocytes, Nitrite, SG, Bilirubin,
Urobilinogen and Blood)(Mission)-To detect Glucose, Protein, pH,
Ketone, Leukocytes, Nitrite, SG, Bilirubin, Urobilinogen and Blood in
Urine,HbA1c Test Kit(The On Call® A1c)-The On Call® A1c Test kit is
used with the On Call® A1c Analyzer to quantitatively determine the
Hemoglobin A1c (HbA1c) level (percentage or mmol/mol) in capillary
or venous whole blood. The On Call® A1c Test Kit includes the
Cartridges and Reagent 1 & 2. They use boronate affinity assay to
separate the glycated hemoglobin fraction from the nonglycated
fraction. The On Call® A1c Test Kit is for professional use only.,3D
Hematology Reagent (Mi-Po Cleaner)(Mission)-Mission® 3D
Hematology Reagent (Mi-Po Cleaner) is intended for use in
conjunction with Mission® HA-360 3-Diff Automatic Hematology
Analyzer for human blood cell analysis, routine/ periodic cleaning and
system maintenance.,Urinalysis Reagent Strips for 14 Parameter
(Glucose, Ascorbic acid, Protein, pH, Ketone, Leukocytes,Nitrite, SG,
Bilirubin, Urobilinogen, Albumin, Creatinine, Calcium and Blood)
(Mission)-To detect Glucose, Ascorbic acid, Protein, pH, Ketone,
Leukocytes, Nitrite, SG, Bilirubin, Urobilinogen,Albumin, Creatinine,
Calcium and Blood,3D Hematology Reagent (Cyto-Lyser)(Mission)-
Mission® 3D Hematology Reagent (Cyto-Lyser) is intended for human
blood cell analysis using in conjunction with Mission® HA-360 3-Diff
Automatic Hematology Analyzer. It can lyse the RBC and release
hemoglobin. It can also modify the WBC.,Urinalysis Reagent Strips for
2 Parameter (Albumin and Creatinine)(Mission)-To detect the Albumin
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5/19/23, 5:58 PM MD - Medical Devices

License
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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
and Creatinine,Liquid Urine Control(Mission)-To validate the visual
and analyzer reading of urinalysis,Hb Hemoglobin Test Strips(Quick
Check Plus)-To detect the Hemoglobin (Hb) and calculated
haematocrit (Hct) in Capillary and Venous whole blood,Urinalysis
Reagent Strips for 2 Parameter (Glucose and Ketone)(Mission)-To
detect the Glucose and Ketone in Urine,Urinalysis Reagent Strips for
2 Parameter (Glucose and Protein)(Mission)-To detect the Glucose
and Protein in Urine,Blood Glucose Test Strips( On Call Plus)-To
measure Glucose level in Capillary blood,Blood Glucose Test Strips
(On Call Extra)-To measure Glucose level in Capillary blood,Urinalysis
Reagent Strips for 1 Parameter (Glucose)(Mission)-To detect the
Glucose in Urine,CHOL Total Cholesterol Testing Strips(Quick Check
Ultra)-To measure Total Cholesterol level in Capillary and Venous
blood

687 IMP/IVD/2020/000006 M/s. Peerless SARS-CoV-2 Antigen Rapid Test(Flowflex SARS-CoV-2 Antigen Rapid CDSCO Class C
Biotech Pvt. Ltd. Test)-A rapid test for the qualitative detection of SARS-CoV-2
nucleocapsid antigens in nasal and nasopharyngeal swab specimens.
,Blood Glucose Monitoring System(On Call Extra)-To measure
Glucose level in Capillary blood,Nucleic Acid Extraction Kit(Promotor
Nucleic Acid Extraction Kit)-The Promotor® Nucleic Acid Extraction Kit
is designed to be used with the Promotor® NES-32 Nucleic Acid
Extraction System for extracting DNA or RNA from various specimens,
such as serum, plasma, swab, sputum. Extracted nucleic acid can be
used in biological applications and clinical molecular diagnostics, such
as, nucleic acid testing, gene cloning and sequencing, PCR,
molecular hybridization, etc.,Blood Glucose Monitoring System(On
Call Plus)-To measure Glucose level in Capillary blood.

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

688 IMP/IVD/2020/000007 Sentier IVD Strips for detection of IgG-F in whole blood or CDSCO Class B
Consulting And serum(ImmuneCheck IgG-F)-Total IgG measurement,Food panel for
Healthcare detection of food allergies(Protia Allergy-Q 64)-For diagnosis of food
Private Limited allergens in human serum,IVD strips for detection of IgG in whole
blood and serum(Immune Check IgG)-For detection of total IgG in
human whole blood and serum,Atopy panel for detection of skin
allergies(Protia Allergy-Q)-Diagnosis of allergies of skin,Allergy
detection panel for food and inhaled allergens(Protia Allergy-Q 96M)-
For detection of allergens in human serum coming from food and
inhaled allergens,Inhalent Panel for detection of inhaled
allergens(Protia Allergy-Q 64)-For diagnosis of allergy generated
through inhalation

689 IMP/IVD/2020/000008 IRIS BILE ACID STANDARD(DIALAB)-Used for calibration of tests for the CDSCO Class B
HEALTHCARE quantitative in vitro determination of bile acids in serum or
TECHNOLOGIES plasma.,SODIUM, ENZYMATIC(DIALAB)-Used for quantitative in-vitro
PRIVATE determination of sodium in human serum on photometric
LIMITED systems.,CHOLINESTERASE, OPT. DGKC(DIALAB)-Used for
quantitative in-vitro determination of cholinesterase in human serum
or plasma on photometric systems.,POTASSIUM,
ENZYMATIC(DIALAB)-Used for quantitative in-vitro determination of
potassium in human serum on photometric systems.,LACTATE,
ENZYMATIC, UV(DIALAB)-Used for quantitative in-vitro determination
of lactate in human plasma or CSF on photometric systems.,BETA-
HYDROXYBUTYRATE STANDARD(DIALAB)-Used for calibration of
tests for the quantitative in vitro determination of beta-hydroxybutyrate
in serum or plasma.,BETA-HYDROXYBUTYRATE, ENZYMATIC,
UV(DIALAB)-Used for quantitative in-vitro determination of beta-
hydroxybutyrate in human serum or plasma on photometric
systems.,BILE ACIDS, ENZYMATIC CYCLING(DIALAB)-Used for
quantitative in-vitro determination of bile acids in human serum or
plasma on photometric systems.,GLUCOSE, GOD-PAP(DIALAB)-
Diagnostic reagent for quantitative in-vitro determination of glucose in
human serum or plasma on photometric systems.

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5/19/23, 5:58 PM MD - Medical Devices

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

690 IMP/IVD/2020/000009 Spectrum PROTIEN STANDARD(MEDICON)-For quantitative determination of CDSCO Class B

Medical PROTIEN STANDARD Activity in Serum/Plasma/Urine
Industries Pvt. Sample,AMMONIA CONTROL(MEDICON)-AMMONIA
Ltd. CONTROL,ALKALINE PHOSPHATASE (ALP)(MEDICON)-For
quantitative determination of ALKALINE PHOSPHASE(ALP) Activity in
Serum/Plasma/Urine Sample,AMMONIA CALIBRATOR(MEDICON)-
AMMONIA CALIBRATOR,AMMONIA(MEDICON)-For quantitative
determination of AMMONIA Activity in Serum/Plasma/Urine
Sample,ALBUMIN(MEDICON)-For quantitative determination of
Albumin Activity in Serum/Plasma/Urine Sample,CRP (MEDICON)-For
quantitative determination of CRP LIQUID Activity in
Serum/Plasma/Urine Sample,CREATININE(MEDICON)-For
quantitative determination of CREATININE Activity in
Serum/Plasma/Urine Sample,HbA1c CALIBRATOR(MEDICON)-
HbA1c CALIBRATOR,HbA1c With HbA1c
DENATURENT(MEDICON)-For quantitative determination of HbA1c
with HbA1c DENATURANT Activity in Serum/Plasma/Urine
Sample,GGT(MEDICON)-For quantitative determination of
CREATININE Activity in Serum/Plasma/Urine Sample,CLINICAL
CHEMISTRY CONTROL L-2(MEDICON)-CLINICAL CHEMISTRY
CONTROL L-2,CK-MB CONTROL(MEDICON)-CK-MB
CONTROL,CK-MB(MEDICON)-For quantitative determination of CK-
MB Activity in Serum/Plasma/Urine Sample,CK(MEDICON)-For
quantitative determination of CK Activity in Serum/Plasma/Urine
Sample,CHOLESTEROL(MEDICON)-For quantitative determination
of CHOLESTEROL Activity in Serum/Plasma/Urine
Sample,CALCIUM(MEDICON)-For quantitative determination of
CALCIUM Activity in Serum/Plasma/Urine
Sample,AST/GOT(MEDICON)-Intended Use: For quantitative
determination of AST/GOT Activity in Serum/Plasma/Urine
Sample,LDL-CHOLESTEROL(MEDICON)-For quantitative
determination of LDL-CHOLESTEROL Activity in Serum/Plasma/Urine
Sample,LDH P-L(MEDICON)-For quantitative determination of LDH P-
L Activity in Serum/Plasma/Urine Sample,IMMUNOLOGY CONTROL
LEVEL-3(MEDICON)-IMMUNOLOGY CONTROL LEVEL-
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5/19/23, 5:58 PM MD - Medical Devices

License
S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
3,IRON(MEDICON)-For quantitative determination of IRON Activity in
Serum/Plasma/Urine Sample,IMMUNOLOGY CONTROL LEVEL-
2(MEDICON)-IMMUNOLOGY CONTROL LEVEL-
2,MICROALBUMIN(MEDICON)-For quantitative determination of
MICROALBUMIN Activity in Serum/Plasma/Urine
Sample,MICROALBUMIN CALIBRATOR(MEDICON)-
MICROALBUMIN CALIBRATOR,MAGNESIUM(MEDICON)-For
quantitative determination of MAGNESIUM Activity in
Serum/Plasma/Urine Sample,HDL-CHOLESTEROL(MEDICON)-For
quantitative determination of HDL-CHOLESTEROL Activity in
Serum/Plasma/Urine Sample,HbA1c Control(MEDICON)-HbA1c
CONTROL,DIRECT BILIRUBIN(MEDICON)-For quantitative
determination of DIRECT BILIRUBIN Activity in Serum/Plasma/Urine
Sample,CRP CALIBRATOR(MEDICON)-CRP CALIBRATOR,a-
AMYLASE(MEDICON)-For quantitative determination of a-AMYLASE
Activity in Serum/Plasma/Urine Sample,URINARY PROTIEN-
CSF(MEDICON)-For quantitative determination of URINARY
PROTIEN-CSF Activity in Serum/Plasma/Urine
Sample,UREA(MEDICON)-For quantitative determination of UREA
Activity in Serum/Plasma/Urine Sample,TOTAL
PROTIEN(MEDICON)-For quantitative determination of TOTAL
PROTIEN Activity in Serum/Plasma/Urine Sample,TOTAL
BILIRUBIN(MEDICON)-For quantitative determination of TOTAL
BILIRUBIN Activity in Serum/Plasma/Urine Sample,RF HIGH
CALIBRATOR(MEDICON)-RF SINGLE POINT CALIBRATOR,URIC
ACID(MEDICON)-For quantitative determination of URIC ACID
Activity in Serum/Plasma/Urine
Sample,TRIGLYCERIDES(MEDICON)-For quantitative determination
of TRIGLYCERIDES Activity in Serum/Plasma/Urine
Sample,UIBC(MEDICON)-For quantitative determination of UIBC
Activity in Serum/Plasma/Urine Sample,RF
CALIBRATOR(MEDICON)-RF CALIBRATOR,CRP
CALIBRATOR(MEDICON)-CRP SINGLE
CALIBRATOR,ALT/GPT(MEDICON)-For quantitative determination of
ALT/GPT Activity in Serum/Plasma/Urine Sample,RF

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
LATEX(MEDICON)-For quantitative determination of RF LATEX
Activity in Serum/Plasma/Urine Sample,PHOSPHORUS(MEDICON)-
For quantitative determination of PHOSPHORUS Activity in
Serum/Plasma/Urine Sample,CLINICAL CHEMISTRY CONTROL L-
1(MEDICON)-CLINICAL CHEMISTRY CONTROL L-1,CK-MB
CALIBRATOR(MEDICON)-CK-MB CALIBRATOR,MEDI-
CAL(MEDICON)-For quantitative determination of MEDI-CAL Activity
in Serum/Plasma/Urine Sample,LIPASE(MEDICON)-For quantitative
determination of LIPASE Activity in Serum/Plasma/Urine
Sample,IMMUNOLOGY CONTROL LEVEL-1(MEDICON)-
IMMUNOLOGY CONTROL LEVEL-1

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691 IMP/IVD/2020/000010 QIAGEN India artus HI Virus-1 QS-RGQ Kit(artus HI Virus-1 QS-RGQ Kit)-The artus CDSCO Class C
Pvt. Ltd HI Virus-1 QS-RGQ Kit is an in vitro nucleic acid amplification test for
the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA
in human biological samples. This diagnostic test kit utilizes the
reverse transcription polymerase chain reaction (RT-PCR) and is
configured for use with the QIAsymphony SP/AS and Rotor-Gene Q
instruments. Sample containing Group M Subtypes A–H have been
validated for use in the assay. The artus HI Virus-1 QS-RGQ Kit is
intended for use in conjunction with clinical presentation and other
laboratory markers for disease prognosis and for use as an aid in
assessing viral response to antiretroviral treatment as measured by
changes in human EDTA plasma HIV-1 RNA levels. The artus HI
Virus-1 QS-RGQ Kit is not intended to be used as a screening test for
HIV or as a diagnostic test to confirm the presence of HIV
infection.,artus HCV QS-RGQ Kit(artus HCV QS-RGQ Kit)-The artus
HCV QS-RGQ Kit is an in vitro nucleic acid amplification test for the
quantitation of hepatitis C virus (HCV) RNA in human EDTA plasma.
This diagnostic test kit utilizes the reverse transcription polymerase
chain reaction (RT-PCR) and is configured for use with the
QIAsymphony SP/AS and Rotor-Gene Q instruments. The artus HCV
QS RGQ Kit is intended for use in conjunction with clinical
presentation and other laboratory markers for disease prognosis and
for use as an aid in assessing viral response to antiviral treatment as
measured by changes in human EDTA plasma HCV RNA levels. The
artus HCV QS-RGQ Kit is not intended to be used as a screening test
for HCV or as a diagnostic test to confirm the presence of HCV
infection.,artus HBV QS-RGQ Kit(artus HBV QS-RGQ Kit)-The artus
HBV QS-RGQ Kit is an in vitro nucleic acid amplification test for the
quantitation of hepatitis B virus (HBV) DNA in human EDTA plasma.
This diagnostic test kit utilizes the polymerase chain reaction (PCR)
and is configured for use with the QIAsymphony SP/AS and Rotor-
Gene Q instruments. The artus HBV QS-RGQ Kit is intended for use
in conjunction with clinical presentation and other laboratory markers
for disease prognosis and for use as an aid in assessing viral
response to antiviral treatment as measured by changes in human
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S. License Holder Approving Device
No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
EDTA plasma HBV DNA levels. The artus HBV QS-RGQ Kit is not
intended to be used as a screening test for HBV or as a diagnostic
test to confirm the presence of HBV infection.,artus HCV RG RT-PCR
Kit(artus HCV RG RT-PCR Kit)-The artus HCV RG RT-PCR Kit is an
in vitro nucleic acid amplification test for the quantitation of hepatitis C
virus (HCV) RNA in human plasma. This diagnostic test kit utilizes the
reverse transcription polymerase chain reaction (RT-PCR) and is
configured for use with Rotor-Gene Q Instruments. The test can
quantitate HCV RNA over the range of 65 – 1 x 106 HCV IU/ml. The
artus HCV RG RT-PCR Kit is intended for use in conjunction with
clinical presentation and other laboratory markers for disease
prognosis and for use as an aid in assessing viral response to
antiretroviral treatment as measured by changes in EDTA plasma
HCV RNA levels. The artus HCV RG RT-PCR Kit is not intended to be
used as a screening test for HCV or as a diagnostic test to confirm the
presence of HCV infection.,artus HBV RG PCR Kit(artus HBV RG
PCR Kit)-The artus HBV RG PCR Kit is an in vitro nucleic acid
amplification test for the quantitation of hepatitis B virus (HBV) DNA in
human plasma. This diagnostic test kit utilizes the polymerase chain
reaction (PCR) and is configured for use with Rotor-Gene Q
Instruments.,QIAstat-Dx Respiratory SARS-CoV-2 Panel(QIAstat-Dx
Respiratory SARS-CoV-2 Panel)-The QIAstat-Dx Respiratory SARS-
CoV-2 Panel is a qualitative test intended for analyzing
nasopharyngeal swab (NPS) samples for the presence of viral or
bacterial nucleic acids. The QIAstat-Dx Respiratory SARS-CoV-2
Panel is able to accept both dry swabs and transport medium liquid
samples. The assay is designed for use with the QIAstat-Dx Analyzer
1.0 for integrated nucleic acid extraction and multiplex real-time RT-
PCR detection.,artus HI Virus-1 RG RT-PCR Kit(artus HI Virus-1 RG
RT-PCR Kit)-The artus HI Virus-1 RG RT-PCR Kit is an in vitro nucleic
acid amplification test for the quantitation of human immunodeficiency
virus type 1 (HIV-1) RNA in human plasma. This diagnostic test kit
utilizes the reverse transcription polymerase chain reaction (RT-PCR)
and is configured for use with Rotor-Gene Q Instruments. The test can
quantitate HIV-1 RNA over the range of 120 – 1 x 108 HIV-1 IU/ml.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
Plasma samples containing Group M Subtypes A–H have been
validated for use in the assay. The artus HI Virus-1 RG RT-PCR Kit is
intended for use in conjunction with clinical presentation and other
laboratory markers for disease prognosis and for use as an aid in
assessing viral response to antiretroviral treatment as measured by
changes in EDTA plasma HIV-1 RNA levels. The artus HI Virus-1 RG
RT-PCR Kit is not intended to be used as a screening test for HIV or
as a diagnostic test to confirm the presence of HIV infection.

692 IMP/IVD/2020/000011 Beckman Coulter HDL-CHOLESTEROL CALIBRATOR(HDL-CHOLESTEROL CDSCO Class B

India Private CALIBRATOR)-The HDL-Cholesterol Calibrator is a lyophilised human
Limited Hisaria serum calibrator intended to be used with the HDL-Cholesterol
Warehouse reagent OSR6187/OSR6287/OSR6687 for the quantitative
Ground Floor determination of HDL-cholesterol on Beckman Coulter
analysers.,CREATININE (ENZYMATIC)(CREATININE (ENZYMATIC))-
Enzymatic assay for the quantitative determination of creatinine in
human serum, plasma and urine on Beckman Coulter AU
analysers.,LDL-CHOLESTEROL(LDL-CHOLESTEROL)-Enzymatic
colour test for the quantitative determination of LDL-cholesterol in
human serum and plasma on Beckman Coulter AU analysers.,HDL-
CHOLESTEROL(HDL-CHOLESTEROL)-Enzymatic colour test for the
quantitative determination of HDL-cholesterol in human serum and
plasma on Beckman Coulter analysers.,LDL-CHOLESTEROL
CALIBRATOR(LDL-CHOLESTEROL CALIBRATOR)-The LDL-
Cholesterol Calibrator is a lyophilised human serum calibrator
intended to be used with the LDL-Cholesterol reagent
OSR6183/OSR6283 for the quantitative determination of LDL-
cholesterol on Beckman Coulter analysers.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

693 IMP/IVD/2020/000012 Abbott Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit(Alinity i CDSCO Class B
Healthcare Pvt. Cyclosporine Whole Blood Precipitation Reagent Kit)-The Alinity i
Ltd. Cyclosporine Whole Blood Precipitation Reagent Kit is for the
extraction of cyclosporine from samples (human whole blood patient
specimens, controls and Alinity i Cyclosporine Calibrators) to be
tested on the Alinity i analyzer.,Alinity i Tacrolimus Whole Blood
Precipitation Reagent(Alinity i Tacrolimus Whole Blood Precipitation
Reagent)-The Alinity i Tacrolimus Whole Blood Precipitation Reagent
is for the extraction of tacrolimus from samples (human whole blood
patient specimens, controls and Alinity i Tacrolimus Calibrators) to be
tested on the Alinity i analyzer.,Alinity i Sirolimus Whole Blood
Precipitation Reagent(Alinity i Sirolimus Whole Blood Precipitation
Reagent)-The Alinity i Sirolimus Whole Blood Precipitation Reagent is
for the extraction of sirolimus from samples (human whole blood
patient specimens, controls and Alinity i Sirolimus Calibrators) to be
tested on the Alinity i analyzer.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

694 IMP/IVD/2020/000012 Abbott ARCHITECT Sirolimus Whole Blood Precipitation CDSCO Class C
Healthcare Pvt. Reagent(ARCHITECT Sirolimus Whole Blood Precipitation Reagent)-
Ltd. The ARCHITECT Sirolimus Whole Blood Precipitation Reagent is for
the extraction of sirolimus from samples (human whole blood patient
specimens, controls and ARCHITECT Sirolimus Calibrators) to be
tested on the ARCHITECT iSystem.,ARCHITECT Tacrolimus Whole
Blood Precipitation Reagent(ARCHITECT Tacrolimus Whole Blood
Precipitation Reagent)-ARCHITECT Tacrolimus Whole Blood
Precipitation Reagent is for the extraction of tacrolimus from samples
(human whole blood patient specimens, controls and ARCHITECT
Tacrolimus Calibrators) to be tested on the ARCHITECT
iSystem.,ARCHITECT Cyclosporine Whole Blood Precipitation
Reagent Kit(ARCHITECT Cyclosporine Whole Blood Precipitation
Reagent Kit)-The ARCHITECT Cyclosporine Whole Blood
Precipitation Reagent Kit is for the extraction of cyclosporine from
samples (human whole blood patient specimens, controls and
ARCHITECT Cyclosporine Calibrators) to be tested on the
ARCHITECT iSystem.

695 IMP/IVD/2020/000013 Shiva Scientific HISTO SPOT Coeliac Disease(HISTO SPOT Coeliac Disease)-In vitro CDSCO Class C
Company diagnostic medical device for professional use Test kit for the
detection of HLA alleles associated with coeliac disease with the SSO
technique.

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696 IMP/IVD/2020/000013 Shiva Scientific HISTO SPOT A 4D(HISTO SPOT A 4D)-In vitro diagnostic medical CDSCO Class D
Company device for professional use Test kit for molecular genetic typing of
HLA-A with the SSO technique. ,HISTO SPOT B 4D(HISTO SPOT B
4D)-In vitro diagnostic medical device for professional use Test kit for
molecular genetic typing of HLA-B with the SSO technique. ,HISTO
SPOT REAGENT KIT(HISTO SPOT REAGENT KIT)-In vitro
diagnostic medical device for professional use Tests kit with reagents
to be used together with the kits from the BAG product line HISTO
SPOT® for molecular genetic HLA typing/detection of disease
associated HLA alleles using the SSO technique. ,HISTO SPOT
DQB1 4D/DQA1(HISTO SPOT DQB1 4D/DQA1)-In vitro diagnostic
medical device for professional use Test kit for molecular genetic
typing of HLA-DQB1 and HLA DQA1 with the SSO technique,HISTO
SPOT DRB1 4D(HISTO SPOT DRB1 4D)-In vitro diagnostic medical
device for professional use Test kit for molecular genetic typing of
HLA-DRB1 with the SSO technique,HISTO SPOT C 4D(HISTO SPOT
C 4D)-In vitro diagnostic medical device for professional use Test kit
for molecular genetic typing of HLA-C with the SSO technique.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

697 IMP/IVD/2020/000014 ASPEN NES-32 Nucleic Acid Extraction System(Promoter)-NES-32 Nucleic CDSCO Class A
DIAGNOSTICS Acid Extraction System is intended for professional use by trained
PVT. LTD. personnel. The instrument is developed to work with the Nucleic Acid
Extraction Kits to extract nucleic acid from various samples, such as
serum, plasma, whole blood, swab, feces or urine, etc. The DNA or
RNA extracted can be used for further downstream analysis, such as
qPCR, gene cloning, sequencing, or molecular hybridization,
etc.,Urine Analyzer-For use in conjunction with Urinalysis Reagent
Strips for the semi-quantitative detection of the following analytes in
human urine: Albumin, Creatinine, Glucose, Bilirubin, Ketone
(Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen,
Leukocytes, Ascorbic Acid and Calcium, as well as the qualitative
detection of Nitrite.,Hemoglobin Testing System(Mission)-Intended for
the quantitative determination of hemoglobin (Hb) and calculated
hematocrit (Hct) in capillary and venous human whole blood.,Urine
Analyzer-For use in conjunction with Urinalysis Reagent Strips for the
semi-quantitative detection of the following analytes in human urine:
Albumin, Creatinine, Glucose, Bilirubin, Ketone (Acetoacetic acid),
Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes,
Ascorbic Acid and Calcium, as well as the qualitative detection of
Nitrite.,Cholesterol Monitoring System(Mission)-Intended for the
quantitative determination of Total Cholesterol (CHOL), High Density
Lipoprotein Cholesterol (HDL), Triglycerides (TRIG), and the
calculated ratio of CHOL/HDL and Low Density Lipoprotein
Cholesterol (LDL) in capillary and venous human whole blood,
plasma, and serum.

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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class

698 IMP/IVD/2020/000014 ASPEN Urine Analysis Reagent Strips-For estimation of Glucose, Bilirubin, CDSCO Class B
DIAGNOSTICS pH, Specific Gravity, Protein, Urobilinogen, Nitrite, Ketone, Blood,
PVT. LTD. Leukocyte, Ascorbic Acid, Microalbumin, Creatinine, Calcium etc. in
urine,Hb Haemoglobin Test Strips-For estimation of
Hemoglobin,CHOL Total Cholesterol Test Strips-For estimation of
Cholesterol,Cholesterol Test Devices-For estimation of Total
Cholesterol, HDL and Triglycerides,Liquid Urine Control-For quality
control of urine analysis reagent strips

699 IMP/IVD/2020/000015 ASPEN AP-Plus Blood Glucose Monitoring System(AP+Plus)-It is a device to CDSCO Class C
DIAGNOSTICS measure the concentration of glucose in blood.,Smart Chek Blood
PVT. LTD. Glucose Monitoring System(Gluco Chek)-It is device to measure the
concentration of glucose in blood,Smart Chek Blood Glucose
Meter(Gluco Chek)-It is device to measure the concentration of
glucose in blood.,AP-Plus Blood Glucose Meter(AP+Plus)-It is a
device to measure the concentration of glucose in blood.,Smart Check
Blood Glucose Test Strips(Gluco Chek)-Measurement of blood
glucose value,AP-Plus Blood Glucose Test Strips(AP+Plus)-
Measurement of blood glucose value

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700 IMP/IVD/2020/000016 M/s.Roche Blood Glucose monitoring strips(Accu-chek Aviva test strips)-The CDSCO Class B
Diabetes Care Accu-Chek Aviva Test Strips are intended to be used with the Accu-
India Private Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek Aviva Connect, Accu-
Limited Chek Aviva Combo, Accu-Chek Aviva Expert, Accu-Chek Aviva
Insight, and Accu-Chek Aviva Solo Blood Glucose Meters to
quantitatively measure glucose in fresh capillary whole blood as an
aid in monitoring the effectiveness of controlling glucose. Testing sites
for the Accu-Chek Aviva, Accu-Chek Aviva Nano and Accu-Chek Aviva
Connect meters include the finger, palm, forearm, and upper arm. The
testing site for the Accu-Chek Aviva Combo, Accu-Chek Aviva Expert,
Accu-Chek Aviva Insight and Accu-Chek Aviva Solo meters is the
fingertip. The Accu-Chek Aviva test strip, used with the Accu-Chek
Aviva, Accu-Chek Aviva Nano, and Accu-Chek Aviva Connect meters,
are intended for in vitro diagnostic use by healthcare professionals in
clinical settings and by people with diabetes at home. The Accu-Chek
Aviva Combo, Accu-Chek Aviva Expert, Accu-Chek Aviva Insight and
Accu-Chek Aviva Solo meters are for home use only. Healthcare
professionals can use venous, arterial, and neonatal blood with the
Accu-Chek Aviva and Accu-Chek Aviva Nano meters. Healthcare
professionals can use capillary and venous blood with the Accu-Chek
Aviva Connect meter. The systems are not for use in diagnosis or
screening of diabetes mellitus, nor for testing neonate cord blood
samples. Venous, arterial, and neonatal blood testing is limited to
healthcare professional use only. ,Blood Glucose Monitoring
Strips(Accu Chek Performa Test Strips)-The Accu‑Chek Performa test
strips are intended to be used with the Accu‑Chek Performa,
Accu‑Chek Performa Nano and Accu‑Chek Performa Solo blood
glucose meters to quantitatively measure glucose in fresh capillary
whole blood as an aid in monitoring the effectiveness of controlling
glucose. Testing sites for the Accu‑Chek Performa and Accu‑Chek
Performa Nano meters include the finger, palm, forearm and upper
arm. The testing site for the Accu-Chek Performa Solo meters is the
fingertip. The Accu‑Chek Performa test strips, used with the
Accu‑Chek Performa and Accu‑Chek Performa Nano meters are
intended for in vitro diagnostic use by healthcare professionals in
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No.  Number  Name  Device Name(Brand Name)-Intended Use  Authority  Class
clinical settings and by people with diabetes at home. The Accu-Chek
Performa Solo meters are for home use only. Healthcare
professionals can use venous, arterial and neonatal blood with the
Accu-Chek Performa and Accu-Chek Performa Nano meters. The
systems are not for use in diagnosis or screening of diabetes mellitus,
nor for testing neonate cord blood samples. Venous, arterial and
neonatal blood testing is limited to healthcare professional use only.

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