Disclaimer: WHO does not endorse any of the lists provided by NRAs.

This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Country Product name Manufacturer/applicant Link

of name
approval
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
BioCore 2019-nCoV framework/emergency-use-authorization#2019-ncov
Real Time PCR Kit BioCore Co., Ltd.
United For updated information on all products listed by the FDA use this link:
States DiaPlexQ Novel https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Coronavirus (2019- framework/emergency-use-authorization#2019-ncov
nCoV) Detection Kit SolGent Co., Ltd.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
AQ-TOP COVID-19 Seasun Biomaterials, framework/emergency-use-authorization#2019-ncov
Rapid Detection Kit Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
P23 Labs TaqPath framework/emergency-use-authorization#2019-ncov
SARS-CoV-2 Assay P23 Labs, LLC.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Lyra Direct SARS-CoV- framework/emergency-use-authorization#2019-ncov
2 Assay Quidel Corporation
United For updated information on all products listed by the FDA use this link:
States Everlywell COVID-19 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Test Home Collection framework/emergency-use-authorization#2019-ncov
Kit Everlywell, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Fulgent COVID-19 by Fulgent Therapeutics, framework/emergency-use-authorization#2019-ncov
RT-PCR Test LLC
1
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Assurance SARS-CoV- Assurance Scientific framework/emergency-use-authorization#2019-ncov
2 Panel Laboratories
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Aptima SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
assay Hologic, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
NeoPlex COVID-19 framework/emergency-use-authorization#2019-ncov
Detection Kit GeneMatrix, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Linea COVID-19 Assay Applied DNA Sciences, framework/emergency-use-authorization#2019-ncov
Kit Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
1copy COVID-19 framework/emergency-use-authorization#2019-ncov
qPCR Multi Kit 1drop Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Alinity m SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
assay Abbott Molecular Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Sofia 2 SARS Antigen framework/emergency-use-authorization#2019-ncov
FIA Quidel Corporation
United For updated information on all products listed by the FDA use this link:
States Gnomegen COVID- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
19-RT-qPCR framework/emergency-use-authorization#2019-ncov
Detection Kit Gnomegen LLC

2
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Quick SARS-CoV- Zymo Research framework/emergency-use-authorization#2019-ncov
2rRT-PCR Kit Corporation
United Rutgers Clinical Rutgers Clinical For updated information on all products listed by the FDA use this link:
States Genomics Laboratory Genomics Laboratory at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
TaqPath SARS-CoV-2- RUCDR Infinite Biologics framework/emergency-use-authorization#2019-ncov
Assay - Rutgers University
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
OPTI SARS-CoV-2 RT OPTI Medical Systems, framework/emergency-use-authorization#2019-ncov
PCR Test Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Sherlock CRISPR Sherlock BioSciences, framework/emergency-use-authorization#2019-ncov
SARS-CoV-2 Kit Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#2019-ncov
SARS-COV-2 R-GENE BioMérieux SA
United Fast Track Diagnostics For updated information on all products listed by the FDA use this link:
States Luxembourg S.á.r.l. (a https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Siemens Healthineers framework/emergency-use-authorization#2019-ncov
FTD SARS-CoV-2 Company)
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Anti-SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
ELISA (IgG) EUROIMMUN US Inc.
United Novel Coronavirus For updated information on all products listed by the FDA use this link:
States (2019-nCoV) Nucleic https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Acid Diagnostic Kit framework/emergency-use-authorization#2019-ncov
(PCR-Fluorescence
Probing) Sansure BioTech Inc.
3
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Elecsys Anti-SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 Roche Diagnostics
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Bio-Rad SARS-CoV-2 Bio-Rad Laboratories, framework/emergency-use-authorization#2019-ncov
ddPCR Test Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
BioFire Respiratory framework/emergency-use-authorization#2019-ncov
Panel 2.1 (RP2.1) BioFire Diagnostics, LLC
United New York SARS-CoV For updated information on all products listed by the FDA use this link:
States Microsphere Wadsworth Center, New https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Immunoassay for York State Department framework/emergency-use-authorization#2019-ncov
Antibody Detection of Health
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
LabGun COVID-19 RT- framework/emergency-use-authorization#2019-ncov
PCR Kit LabGenomics Co., Ltd.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Rheonix COVID-19 framework/emergency-use-authorization#2019-ncov
MDx Assay Rheonix, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Platelia SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
Total Ab assay Bio-Rad Laboratories
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
U-TOP COVID-19 framework/emergency-use-authorization#2019-ncov
Detection Kit SEASUN BIOMATERIALS

4
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#2019-ncov
SARS-CoV-2 IgG assay Abbott Laboratories Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
LIAISON SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
S1/S2 IgG DiaSorin Inc.
United VITROS For updated information on all products listed by the FDA use this link:
States Immunodiagnostic https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Products Anti-SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 IgG Reagent Ortho-Clinical
Pack Diagnostics, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Anti-SARS-CoV-2 Autobio Diagnostics Co. framework/emergency-use-authorization#2019-ncov
Rapid Test Ltd.
United For updated information on all products listed by the FDA use this link:
States STANDARD M nCoV https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Real-Time Detection framework/emergency-use-authorization#2019-ncov
Kit SD Biosensor, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
RealStar SARS-CoV02 altona Diagnostics framework/emergency-use-authorization#2019-ncov
RT-PCR Kits U.S. GmbH
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Allplex 2019-nCoV framework/emergency-use-authorization#2019-ncov
Assay Seegene, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Trax Management framework/emergency-use-authorization#2019-ncov
PhoenixDx 2019-CoV Services Inc.
5
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
GeneFinder COVID- framework/emergency-use-authorization#2019-ncov
19 Plus RealAmp Kit OSANG Healthcare
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Fosun COVID-19 RT- framework/emergency-use-authorization#2019-ncov
PCR Detection Kit Fosun Pharma USA Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
GS COVID-19 RT-PCR framework/emergency-use-authorization#2019-ncov
KIT GenoSensor, LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Curative-Korva SARS- framework/emergency-use-authorization#2019-ncov
Cov-2 Assay KorvaLabs Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
SARS-CoV-2 Maccura Biotechnology framework/emergency-use-authorization#2019-ncov
Fluorescent PCR Kit (USA) LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
COVID-19 ELISA IgG framework/emergency-use-authorization#2019-ncov
Antibody Test Mount Sinai Laboratory
United VITROS For updated information on all products listed by the FDA use this link:
States Immunodiagnostic https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Products Anti-SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 Total Reagent Ortho Clinical
Pack Diagnostics, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
DPP COVID-19 Chembio Diagnostic framework/emergency-use-authorization#2019-ncov
IgM/IgG System System, Inc.
6
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
iAMP COVID-19 framework/emergency-use-authorization#2019-ncov
Detection Kit Atila BioSystems, Inc.
United For updated information on all products listed by the FDA use this link:
States BD SARS-CoV- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
2Reagents for BD Becton, Dickinson & framework/emergency-use-authorization#2019-ncov
MAX System Company
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
QuantiVirus SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 Test kit DiaCarta, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Smart Detect SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 rRT-PCR Kit InBios International, Inc.
United For updated information on all products listed by the FDA use this link:
States Gnomegen COVID-19 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
RT-Digital PCR framework/emergency-use-authorization#2019-ncov
Detection Kit Gnomegen LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
ARIES SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
Assay Luminex Corporation
United ScienCell SARS-CoV-2 For updated information on all products listed by the FDA use this link:
States Coronavirus Real- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
time RT-PCR (RT- ScienCell Research framework/emergency-use-authorization#2019-ncov
qPCR) Detection Kit Laboratories
United For updated information on all products listed by the FDA use this link:
States Logix Smart https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Coronavirus Disease framework/emergency-use-authorization#2019-ncov
2019 (COVID-19) Kit Co-Diagnostics, Inc.

7
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States BioGX SARS-CoV-2 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Reagents for BD MAX Becton, Dickinson & framework/emergency-use-authorization#2019-ncov
System Company (BD)
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
qSARS-CoV-2 IgG/IgM framework/emergency-use-authorization#2019-ncov
Rapid Test Cellex Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#2019-ncov
COV-19 IDx assay Ipsum Diagnostics, LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
NeuMoDx SARS-CoV- NeuMoDx Molecular, framework/emergency-use-authorization#2019-ncov
2 Assay Inc.
United For updated information on all products listed by the FDA use this link:
States QIAstat-Dx https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Respiratory SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 Panel QIAGEN GmbH
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Abbott Diagnostics framework/emergency-use-authorization#2019-ncov
ID NOW COVID-19 Scarborough, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
NxTAG CoV Extended Luminex Molecular framework/emergency-use-authorization#2019-ncov
Panel Assay Diagnostics, Inc.
United Real-Time For updated information on all products listed by the FDA use this link:
States Fluorescent RT-PCR https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Kit for Detecting framework/emergency-use-authorization#2019-ncov
SARS-CoV-2 BGI Genomics Co. Ltd

8
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#2019-ncov
AvellinoCoV2 test Avellino Lab USA, Inc.
United For updated information on all products listed by the FDA use this link:
States PerkinElmer New https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Coronavirus Nucleic framework/emergency-use-authorization#2019-ncov
Acid Detection Kit PerkinElmer, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
BioFire COVID-19 framework/emergency-use-authorization#2019-ncov
Test BioFire Defense, LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Accula SARS-Cov-2 framework/emergency-use-authorization#2019-ncov
Test Mesa Biotech Inc.
United For updated information on all products listed by the FDA use this link:
States Primerdesign Ltd https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
COVID-19 genesig framework/emergency-use-authorization#2019-ncov
Real-Time PCR assay Primerdesign Ltd
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Xpert Xpress SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 test Cepheid
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Simplexa COVID-19 framework/emergency-use-authorization#2019-ncov
Direct DiaSorin Molecular LLC
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
ePlex SARS-CoV-2 GenMark Diagnostics, framework/emergency-use-authorization#2019-ncov
Test Inc.

9
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Abbott RealTime framework/emergency-use-authorization#2019-ncov
SARS-CoV-2 assay Abbott Molecular
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Lyra SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
Assay Quidel Corp.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Quest SARS-CoV-2 Quest Diagnostics framework/emergency-use-authorization#2019-ncov
rRT-PCR Infectious Disease, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Panther Fusion SARS- framework/emergency-use-authorization#2019-ncov
CoV-2 Assay Hologic, Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
COVID-19 RT-PCR Laboratory Corporation framework/emergency-use-authorization#2019-ncov
Test of America
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
TaqPath COVID-19 Thermo Fisher Scientific, framework/emergency-use-authorization#2019-ncov
Combo Kit Inc.
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Roche Molecular framework/emergency-use-authorization#2019-ncov
cobas SARS-CoV-2 Systems, Inc. (RMS)
United New York SARS-CoV- For updated information on all products listed by the FDA use this link:
States 2 Real-time Reverse https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Transcriptase (RT)- Wadsworth Center, framework/emergency-use-authorization#2019-ncov
PCR Diagnostic Panel NYSDOH

10
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

United CDC 2019-Novel For updated information on all products listed by the FDA use this link:
States Coronavirus (2019- https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
nCoV) Real-Time RT- framework/emergency-use-authorization#2019-ncov
PCR Diagnostic Panel CDC
United For updated information on all products listed by the FDA use this link:
States LetsGetChecked PrivaPath Diagnostics, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Coronavirus (COVID- Inc. framework/emergency-use-authorization#2019-ncov
19) Test
United For updated information on all products listed by the FDA use this link:
States https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-
Hymon SARS-CoV-2 framework/emergency-use-authorization#2019-ncov
Test Kit dba SpectronRx
For updated information on all products listed by Health Canada use this link:
1DROP INC. (imported
1copy COVID-19 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada by Luminarie Canada
QPCR Kit devices/covid-19/diagnostic-devices-authorized.html
Inc.)(South Korea)
For updated information on all products listed by Health Canada use this link:
Abbott Realtime Abbott Molecular Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada
SARS-COV-2 (United States) devices/covid-19/diagnostic-devices-authorized.html

For updated information on all products listed by Health Canada use this link:
Allplex 2019-NCoV https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada Seegene Inc. (Korea)
Assay devices/covid-19/diagnostic-devices-authorized.html

For updated information on all products listed by Health Canada use this link:
BD SARS-CoV-2 BD Integrated
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada Reagents For BD Max Diagnostic Solutions
devices/covid-19/diagnostic-devices-authorized.html
System (Canada)
Biofire COVID - 19 For updated information on all products listed by Health Canada use this link:
Test & Biofire COVID https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Biofire Defense LLC
Canada - 19 External Control devices/covid-19/diagnostic-devices-authorized.html
(United States)
Test Kit (+)Table 1 -
Footnote 2
11
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

For updated information on all products listed by Health Canada use this link:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada cobas SARS-CoV-2 Roche (United States) devices/covid-19/diagnostic-devices-authorized.html

DiaPlexQ Novel For updated information on all products listed by Health Canada use this link:
Life Sciences Research
Canada Coronavirus (2019- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Institute (South Korea)
nCoV) Detection Kit devices/covid-19/diagnostic-devices-authorized.html
DiaSorin Simplexa For updated information on all products listed by Health Canada use this link:
COVID-19 Direct https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
DiaSorin Molecular LLC
Canada Molecular Assay on devices/covid-19/diagnostic-devices-authorized.html
(United States)
the LIAISON MDX
Instrument
For updated information on all products listed by Health Canada use this link:
Genefinder CoVid-19 Osang Healthcare Co.,
Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Plus Realamp Kit Ltd. (South Korea)
devices/covid-19/diagnostic-devices-authorized.html
Liaison Sars-Cov-2 For updated information on all products listed by Health Canada use this link:
S1/S2 IgG, Liaison https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada Diasorin Inc.
Control Sars-Cov-2 devices/covid-19/diagnostic-devices-authorized.html
S1/S2 IgG
Diagnostic Hybrids, Inc. - For updated information on all products listed by Health Canada use this link:
LYRA SARS-COV-2 Also trading as Quidel https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Canada
ASSAY Corporation (United devices/covid-19/diagnostic-devices-authorized.html
States)
Luminex Molecular For updated information on all products listed by the TGA use this link:
NxTAG COV Extended
Canada Diagnostics, Inc. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Panel
(Canada) devices/covid-19/diagnostic-devices-authorized.html
PerkinElmer New For updated information on all products listed by the TGA use this link:
PerkinElmer, Inc.
Canada Coronavirus Nucleic https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(United States)
Acid Detection Kit devices/covid-19/diagnostic-devices-authorized.html
Real-time BGI Americas Corp. For updated information on all products listed by the TGA use this link:
Canada
Fluorescent RT-PCR (United States)

12
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Kit For Detecting https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-

2019-NCOV devices/covid-19/diagnostic-devices-authorized.html
SARS-CoV-2 Assay For updated information on all products listed by the TGA use this link:
Canada (Panther Fusion Hologic (United States) https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
System) devices/covid-19/diagnostic-devices-authorized.html
Abbott Laboratories , For updated information on all products listed by the TGA use this link:
Canada SARS-CoV-2 IgG Assay Diagnostics Division https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(United States) devices/covid-19/diagnostic-devices-authorized.html
For updated information on all products listed by the TGA use this link:
Spartan Cube COVID- Spartan Bioscience Inc.
Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
19 System (Canada)
devices/covid-19/diagnostic-devices-authorized.html
For updated information on all products listed by the TGA use this link:
TaqPathTM COVID-19 Thermo Fisher (United
Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Combo Kit States)
devices/covid-19/diagnostic-devices-authorized.html
For updated information on all products listed by the TGA use this link:
Xpert Xpress SARS-
Canada Cepheid (United States) https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
CoV-2
devices/covid-19/diagnostic-devices-authorized.html
Qiastat-DX For updated information on all products listed by the TGA use this link:
Qiagen Gmbh
Canada Respiratory SARS- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
(Germany)
CoV-2 Panel devices/covid-19/diagnostic-devices-authorized.html
For updated information on all products listed by the TGA use this link:
Biofire Respiratory Biofire Diagnostics, LLC.
Canada https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-
Panel 2.1 (RP2.1) (United States)
devices/covid-19/diagnostic-devices-authorized.html
Japan Sysmex Corporation 2019-nCoV For updated information on all products listed by the TGA use this link:
Fluorescence Detection https://www.mhlw.go.jp/stf/newpage_11332.html
Real-time RT-PCR Kit and
https://www.pmda.go.jp/english/about-pmda/0002.html

Japan Eiken Chemical Co., Loopamp Novel For updated information on all products listed by the TGA use this link:
Ltd. Coronavirus 2019 (SARS- https://www.mhlw.go.jp/stf/newpage_11332.html
CoV-2) Detection Kit and
https://www.pmda.go.jp/english/about-pmda/0002.html

13
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Japan Roche Diagnostics cobas SARS-CoV-2 For updated information on all products listed by the TGA use this link:
K.K. https://www.mhlw.go.jp/stf/newpage_11332.html
and
https://www.pmda.go.jp/english/about-pmda/0002.html
Japan TaqPath Real Time Life Technologies Japan For updated information on all products listed by the TGA use this link:
PCR Reagent Kit for Ltd. https://www.mhlw.go.jp/stf/newpage_11332.html
SARS-CoV-2 and
https://www.pmda.go.jp/english/about-pmda/0002.html
Japan For updated information on all products listed by the TGA use this link:
Xpert® Xpress Cepheid Inc., Beckman https://www.mhlw.go.jp/stf/newpage_11332.html
SARS-CoV-2 Coulter, Inc. and
https://www.pmda.go.jp/english/about-pmda/0002.html
Japan For updated information on all products listed by the TGA use this link:
ESPLINE SARS-CoV- https://www.mhlw.go.jp/stf/newpage_11332.html
Fujirebio Inc.
2 and
https://www.pmda.go.jp/english/about-pmda/0002.html
Japan For updated information on all products listed by the TGA use this link:
MEDICAL＆BIOLOGICAL https://www.mhlw.go.jp/stf/newpage_11332.html
MEBRIGHT SARS- LABORATORIES CO., and
CoV-2 Kit LTD. https://www.pmda.go.jp/english/about-pmda/0002.html
Japan For updated information on all products listed by the TGA use this link:
FilmArray Respiratory https://www.mhlw.go.jp/stf/newpage_11332.html
bioMérieux Japan Ltd.
Panel 2.1 and
https://www.pmda.go.jp/english/about-pmda/0002.html
Australia COVID-19 IgG/IgM Nantong Egens For updated information on all products listed by the TGA use this link:
Rapid Test Kit Biotechnology Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China)
Australia NTBIO One Step NTBIO Diagnostics Inc For updated information on all products listed by the TGA use this link:
Rapid Test - COVID- (Canada) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
19 IgG/IgM Antibody
Test

14
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia BD SARS-CoV-2 Becton Dickinson and For updated information on all products listed by the TGA use this link:
Reagents for BD Company (United States https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
MAX™ System Of America)
Australia Wantai SARS-CoV-2 Beijing Wantai For updated information on all products listed by the TGA use this link:
Ab Rapid Test kit Biologicalpharmacy https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Enterprise Co Ltd
(China) (Life Clinic
Australia Pty Ltd)
Australia Real-time fluorescent BGI Europe A/S For updated information on all products listed by the TGA use this link:
RT-PCR kit for (Denmark) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
detecting SARS-CoV-2
Australia Cellex qSARS-CoV-2 Cellex Inc (United States For updated information on all products listed by the TGA use this link:
IgG/IgM Cassette Of America) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test kit
Australia Xpert® Xpress SARS- Cepheid (USA) (Cepheid For updated information on all products listed by the TGA use this link:
CoV-2 Holdings Pty Ltd) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia VIASURE SARS-CoV-2 CerTest Biotec SL (Spain) For updated information on all products listed by the TGA use this link:
Real Time PCR (Abacus dx Pty Ltd) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit
Australia VIASURE SARS-CoV-2 CerTest Biotec SL (Spain) For updated information on all products listed by the TGA use this link:
S gene Real Time PCR (Becton Dickinson Pty https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit Ltd)
Australia Aridia COVID-19 Real- CTK Biotech Inc (United For updated information on all products listed by the TGA use this link:
Time PCR Test States Of America) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia OnSite COVID-19 CTK Biotech Inc (USA) For updated information on all products listed by the TGA use this link:
IgG/IgM Rapid Test https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia Anti-SARS-CoV-2 EUROIMMUN For updated information on all products listed by the TGA use this link:
ELISA (IgA) Medizinische https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Labordiagnostika AG

15
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia Anti-SARS-CoV-2 EUROIMMUN For updated information on all products listed by the TGA use this link:
ELISA (IgG) Medizinische https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Labordiagnostika AG
Australia EURORealTime SARS- EUROIMMUN For updated information on all products listed by the TGA use this link:
CoV-2 Medizinische https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Labordiagnostika AG
Australia GenBody COVID-19 GenBody Inc (Korea - For updated information on all products listed by the TGA use this link:
IgM/IgG Republic of) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia EasyScreen™ SARS- Genetic Signatures Ltd For updated information on all products listed by the TGA use this link:
CoV-2 Detection Kit (Australia) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia SARS-CoV-2 Antibody Guangzhou Wondfo For updated information on all products listed by the TGA use this link:
Test (Lateral Flow Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Method) (Allsafe Medical Pty Ltd)
Australia SARS-CoV-2 Antibody Guangzhou Wondfo For updated information on all products listed by the TGA use this link:
Test (Lateral Flow Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Method) (Tayler Dental
Consulting Pty Ltd)
Australia SARS-CoV-2 Antibody Guanngzhou Wondfo For updated information on all products listed by the TGA use this link:
Test (Lateral Flow Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Method) (Advangen International
Pty Ltd)
Australia 2019-n-CoV IgG/IgM Hangzhou Alltest For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(AM Diagnostics)
Australia COVID-19 IgG/IgM Hangzhou Biotest For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Medsupply Australia
Pty Ltd)

16
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia COVID-19 IgG/IgM Hangzhou Clongene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(APAC Security Pty Ltd)
Australia COVID-19 IgG/IgM Hangzhou Clongene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Ausliance Group Pty
Ltd)
Australia COVID-19 IgG/IgM Hangzhou Clongene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Zenpharm Pty Ltd)
Australia 2019-nCOV/COVID- Hangzhou Realy Tech Co For updated information on all products listed by the TGA use this link:
19 IgG/IgM Rapid Ltd (China) (Solasta Life https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Test Device Pty Ltd)
Australia COVID-19 IgG/IgM Healgen Scientific For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Limited Liability https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Company (USA)
Australia Panther Fusion® Hologic Inc (USA) For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Assay https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Panther Fusion®
System)
Australia InnoScreenTM Innovation Scientific Pty For updated information on all products listed by the TGA use this link:
COVID-19 IgG/IgM Ltd (Australia) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Rapid Test
Australia 2019-nCoV Ab Test Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
(Colloidal Gold) Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Co Ltd (China) (AM
Diagnostics)
Australia 2019-nCoV Ab Test Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
(Colloidal Gold) Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Co Ltd (China) (Aurora
Future Education
Group)

17
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia 2019-nCoV Ab Test Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
(Colloidal Gold) Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Co Ltd (China) (Endo X)
Australia 2019-nCov Ab Test Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
(Colloidal Gold) Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Co Ltd (China) (Laser
Corporation Holdings
Pty Limited)
Australia 2019-nCoV Ab Test Innovita (Tangshan) For updated information on all products listed by the TGA use this link:
(Colloidal Gold) Biological Technology https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Co Ltd (China) (TrendBio
Pty Ltd)
Australia COVID-19 Jiangsu Bioperfectus For updated information on all products listed by the TGA use this link:
Coronavirus Real Technologies Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time PCR Kit (China) (Sonictec )
Australia PowerChekTM 2019- Kogene Biotech Co Ltd For updated information on all products listed by the TGA use this link:
nCoV Real-time PCR (Korea - Republic of) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Kit
Australia TaqPath COVID-19 Life Technologies For updated information on all products listed by the TGA use this link:
Combo Kit Corporation (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia Abbott RealTime Molecular Division For updated information on all products listed by the TGA use this link:
SARS-CoV-2 Abbott Molecular Inc https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(United States Of
America)
Australia PCL COVID19 IgG/IgM PCL Inc (Korea - For updated information on all products listed by the TGA use this link:
Rapid Gold Republic of) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia QIAstat-Dx® Qiagen GmbH For updated information on all products listed by the TGA use this link:
Respiratory SARS- https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
CoV-2 Panel

18
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia SARS-CoV-2 IgM/lgG Qingdao Hightop For updated information on all products listed by the TGA use this link:
Antibody Rapid Test Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(CK Surgitech Pty Ltd)
Australia SARS-CoV-2 IgM/IgG Qingdao Hightop For updated information on all products listed by the TGA use this link:
Antibody Rapid Test Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Envon Pty Ltd)
Australia Elecsys Anti-SARS- Roche Diagnostics For updated information on all products listed by the TGA use this link:
CoV-2 GmbH https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia cobas® SARS-CoV-2 Roche Molecular For updated information on all products listed by the TGA use this link:
Systems Inc (USA) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia Allplex™ 2019-nCoV Seegene Inc (Korea - For updated information on all products listed by the TGA use this link:
Assay Republic of) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

Australia Novel Coronavirus Shanghai Fosun Long For updated information on all products listed by the TGA use this link:
(2019-nCoV) RT-PCR March Medical Science https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Detection Kit Co Ltd (China) (Alma
Lasers Australia Pty Ltd )
Australia Novel Coronavirus Shanghai ZJ Bio-Tech Co For updated information on all products listed by the TGA use this link:
(2019-nCoV) Real Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Time Multiplex RT-
PCR Kit (Detection for
3 genes)
Australia EasyNat Diagnostic Ustar Biotechnologies For updated information on all products listed by the TGA use this link:
Kit for Novel- (Hangzhou) Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Coronavirus (2019- (China)
nCoV) RNA
(Isothermal
Amplification-Real
Time Fluorescence
Assay)

19
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Australia VivaDiag™ COVID-19 VivaCheck Biotech For updated information on all products listed by the TGA use this link:
IgM/IgG Rapid Test (Hangzhou) Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China) (Endo X Pty Ltd)
Australia VivaDiag™ COVID-19 VivaChek Biotech For updated information on all products listed by the TGA use this link:
IgM/IgG Rapid Test (Hangzhou) Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China) (Device
Technologies Australia
Pty Ltd)
Australia VivaDiag™ COVID-19 VivaChek Biotech For updated information on all products listed by the TGA use this link:
IgM/IgG Rapid Test (Hangzhou) Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China) (Stonestar
Wholesale Pty Ltd)
Australia COVID-19 (SARS-CoV- Wuhan EasyDiagnosis For updated information on all products listed by the TGA use this link:
2) Nucleic Acid Test Biomedicine Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
kit (China)
Australia SARS-CoV-2 IgM/IgG Wuhan EasyDiagnosis For updated information on all products listed by the TGA use this link:
Antibody Test Kit Biomedicine Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China)
Australia COVID-19 IgG/IgM Zhejiang Orient Gene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Amandla China Pty
Limited)
Australia COVID 19 IgG/IgM Zhejiang Orient Gene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Expia Pty Ltd)
Australia COVID-19 IgG/IgM Zhejiang Orient Gene For updated information on all products listed by the TGA use this link:
Rapid Test Cassette Biotech Co Ltd (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(Onsite Diagnostics Pty
Ltd)
Australia Diagnostic Kit for Zhuhai Livzon For updated information on all products listed by the TGA use this link:
IgM/IgG Antibody to Diagnostics Inc (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia

20
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Coronavirus (SARS- (Emergence Technology

CoV-2) (Lateral Flow) Pty Ltd)
Australia Diagnostic Kit for Zhuhai Livzon For updated information on all products listed by the TGA use this link:
IgM/IgG Antibody to Diagnostics Inc (China) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
Coronavirus (SARS- (Marcel Equity Pty
CoV-2) (Lateral Flow) Limited/Avania PL)
Australia COVID-19 IgG/IgM Nantong Egens For updated information on all products listed by the TGA use this link:
Rapid Test Kit Biotechnology Co Ltd https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
(China)
Australia NTBIO One Step NTBIO Diagnostics Inc For updated information on all products listed by the TGA use this link:
Rapid Test - COVID- (Canada) https://www.tga.gov.au/covid-19-diagnostic-tests-included-artg-legal-supply-australia
19 IgG/IgM Antibody
Test
Singapore Abbott RealTime Abbott Laboratories For updated information on all products listed by the HSA use this link:
SARS-CoV-2 assay (Singapore) Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation

Singapore Abbott SARS-CoV- Abbott Laboratories For updated information on all products listed by the HSA use this link:
2 IgG – (S) Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
ARCHITECT assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
abTES™ COVID-
AITbiotech Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19 qPCR I Kit
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Acu-Corona 3.0 Acumen Research For updated information on all products listed by the HSA use this link:
Laboratories Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Acu-Corona™ 2.0 Acumen Research For updated information on all products listed by the HSA use this link:
Laboratories https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Allplex 2019-nCoV Genomax For updated information on all products listed by the HSA use this link:
Assay Technologies Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
21
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Singapore altona Diagnostics For updated information on all products listed by the HSA use this link:
RealStar™ SARS-CoV- SDT Molecular Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2 RT-PCR Kit 1.0 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
AMT RESOLUTE 1.0 AMT Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore BD SARS-CoV-2 Becton Dickinson For updated information on all products listed by the HSA use this link:
Reagents for BD Holding Ptd Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
MAX™ System 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
BioFire® Respiratory BioMérieux Singapore
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Panel 2.1 (RP2.1) Pte Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
BIOSYNEX COVID-19
COBS Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
BSS
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore BioWalker SARS- BioWalker Pte Ltd For updated information on all products listed by the HSA use this link:
CoV-2 Assay https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore BioWalker SARS- BioWalker Pte Ltd For updated information on all products listed by the HSA use this link:
CoV-2 Assay 2.0 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Camtech COVID-19 Camtech Diagnostics For updated information on all products listed by the HSA use this link:
IgM/IgG Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Cepheid® Xpert® SPD Scientific Pte For updated information on all products listed by the HSA use this link:
Xpress SARS-CoV- Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
Cobas® SARS- Roche Diagnostics
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
CoV-2 Asia Pacific Pte Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore DiagnoSure Grit Overseas Pte Ltd For updated information on all products listed by the HSA use this link:
COVID-19 IgG/ IgM

22
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Rapid Test https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-

Cassette 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore EDI™ Novel For updated information on all products listed by the HSA use this link:
All Eights (Singapore)
Coronavirus COVID- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pte Ltd
19 IgG ELISA Kit 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Diagnostics For updated information on all products listed by the HSA use this link:
FORTITUDE KIT
Development Hub https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2.0
(DxD) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Fortitude™ Kit 2.1 Diagnostics For updated information on all products listed by the HSA use this link:
Development Hub https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
(DxD) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Fosun Novel For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Novena Global https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) RT-PCR Healthcare Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Detection Kit
Singapore For updated information on all products listed by the HSA use this link:
Siemens Healthcare Pte
FTD™ SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
GeneFinder™ COVID-
SPD Scientific Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19 Plus RealAmp Kit
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore HealthGroup Medical For updated information on all products listed by the HSA use this link:
V-CODE Sars-CoV-2 Healthgroup Medical https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
(COVID-19) IgG/IgM Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Rapid Test
Singapore INNOVITA 2019- Bioforge Solutions Pte For updated information on all products listed by the HSA use this link:
nCoV Ab Test Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
(Colloidal Gold) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore INNOVITA 2019-nCoV For updated information on all products listed by the HSA use this link:
Biomed Diagnostics Pte
Ab Test (Colloidal https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Ltd
Gold) 19-diagnostic-tests-in-singapore-via-provisional-authorisation

23
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Singapore INNOVITA 2019-nCoV For updated information on all products listed by the HSA use this link:
Ying Assets
Ab Test (Colloidal https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Management Pte Ltd
Gold) 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore i-Test COVID -19 Grey Solutions Pte Ltd For updated information on all products listed by the HSA use this link:
IgM/IgG Antibody https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Rapid Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(Colloidal Gold)
Singapore i-Test COVID -19 For updated information on all products listed by the HSA use this link:
IgM/IgG Antibody https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
I-Test Pte Ltd
Rapid Test (Colloidal 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Gold)
Singapore Kit for Novel- Biowalker Pte Ltd For updated information on all products listed by the HSA use this link:
Coronavirus (2019- https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) RNA 19-diagnostic-tests-in-singapore-via-provisional-authorisation
(Isothermal
Amplification-Real
Time Fluorescence
Assay)
Singapore Liferiver Novel Tanglin Cardiology For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) Real Time 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Multiplex RT-PCR
Kit
Singapore Liferiver Novel Biomed Diagnostics For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) Real Time 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Multiplex RT-PCR
Kit
Singapore Liferiver Novel For updated information on all products listed by the HSA use this link:
Coronavirus (2019- Biomed Diagnostics Pte https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV) Real Time Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Multiplex RT-PCR Kit
Singapore Luminex NxTAG® CoV Biomed Diagnostics Pte For updated information on all products listed by the HSA use this link:
Extended Panel Assay Ltd
24
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore MiRXES MiRXES Pte Ltd For updated information on all products listed by the HSA use this link:
FORTITUDE KIT https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2.0 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
MiRXES Fortitude Kit
MiRXES Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
2.1
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore MP Diagnostics For updated information on all products listed by the HSA use this link:
MP Biomedicals Asia
ASSURE® SARS-CoV-2 https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Pacific Pte Ltd
IgG/IgM Rapid Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Nanjing Vazyme Biolidics For updated information on all products listed by the HSA use this link:
2019-nCoV IgG/IgM Limited https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Detection Kit also 19-diagnostic-tests-in-singapore-via-provisional-authorisation
marketed as
Biolidics 2019-
nCoV IgG/IgM
Detection Kit
Singapore PerkinElmer® PerkinElmer For updated information on all products listed by the HSA use this link:
SARS-CoV-2 Real- Singapore Pte https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
time RT-PCR Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Assay
Singapore For updated information on all products listed by the HSA use this link:
ProTect™ COVID-
JN Medsys Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19 RT-qPCR Kit
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Real-time BGI Health (SG)
Fluorescent RT- Company Pte Ltd
PCR kit for
detecting SARS-
CoV-2
Singapore Real-Time PCR For updated information on all products listed by the HSA use this link:
Assay for the DSO National https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Detection of SARS- Laboratories 19-diagnostic-tests-in-singapore-via-provisional-authorisation
CoV-2 Virus
25
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Singapore Roche Elecsys Roche Diagnostics For updated information on all products listed by the HSA use this link:
Anti-SARS-CoV-2 Asia Pacific Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Sansure Biotech Medicell For updated information on all products listed by the HSA use this link:
Novel Pharmaceutical (S) https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Coronavirus(2019- Pte Ltd 19-diagnostic-tests-in-singapore-via-provisional-authorisation
nCoV) Nucleic Acid
Diagnostic Kit
Singapore Seegene All Eights (Singapore) For updated information on all products listed by the HSA use this link:
AllplexTM 2019- Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
nCoV Assay 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Shanghai LiangRun For updated information on all products listed by the HSA use this link:
LionRun Diagnostic https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Kit for Antibody IgM- Veredus Laboratories 19-diagnostic-tests-in-singapore-via-provisional-authorisation
IgG of Novel Pte Ltd
Coronavirus COVID-
19
Singapore For updated information on all products listed by the HSA use this link:
TaqPath™ COVID- Life Technologies
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19 Combo Kit Holdings Pte Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
VereCoV™ Veredus Laboratories
https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Detection Kit Pte Ltd
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore ViroKey SARS- Vela Operations For updated information on all products listed by the HSA use this link:
CoV-2 RT-PCR Singapore Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore VitaPCR™ SARS- Credo Diagnostics For updated information on all products listed by the HSA use this link:
CoV-2 Assay Biomedical Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore VITROS For updated information on all products listed by the HSA use this link:
Ortho Clinical
Immunodiagnostic https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Diagnostics
Products Anti-SARS- 19-diagnostic-tests-in-singapore-via-provisional-authorisation

26
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

CoV-2 Total Reagent

Pack
Singapore VivaDiag™ COVID- For updated information on all products listed by the HSA use this link:
19 IgM/IgG Rapid Everest Links Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore For updated information on all products listed by the HSA use this link:
VivaDiag™ COVID-19
Everest Links Pte Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
IgM/IgG Rapid Test
19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Wondfo SARS- SkyQuest Pte Ltd For updated information on all products listed by the HSA use this link:
CoV-2 Antibody https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Singapore Wondfo SARS- Bioforge Solutions Pte For updated information on all products listed by the HSA use this link:
CoV-2 Antibody Ltd https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Test (Lateral Flow 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Method)
Singapore Xiamen Boson Rapid For updated information on all products listed by the HSA use this link:
Trans Sahara
2019-nCOV IgG/IgM https://www.hsa.gov.sg/announcements/regulatory-updates/hsa-expedites-approval-of-covid-
Corporation Pte Ltd
Combo Test Card 19-diagnostic-tests-in-singapore-via-provisional-authorisation
Brazil Novo kit de teste de 1000MEDIC For updated information on all products listed by ANVISA use this link:
anticorpos IgM /IgG DISTRIBUIDORA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
para coronavirus IMPORTADORA
(2019-nCoV) (ouro EXPORTADORA DE
coloidal) MEDICAMENTOS LTDA
Brazil For updated information on all products listed by ANVISA use this link:
Família SARS-CoV-2 ABBOTT LABORATÓRIOS
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IgG DO BRASIL LTDA
Brazil Família Abbott For updated information on all products listed by ANVISA use this link:
RealTime SARS-CoV-2 ABBOTT LABORATÓRIOS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
EUA DO BRASIL LTDA
Brazil For updated information on all products listed by ANVISA use this link:
Família Abbott ABBOTT LABORATÓRIOS
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
RealTime SARS-CoV-2 DO BRASIL LTDA

27
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil ABS COMERCIO E For updated information on all products listed by ANVISA use this link:
Família Abbott
IMPORTACAO LTDA - https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
RealTime SARS-CoV-2
EPP
Brazil For updated information on all products listed by ANVISA use this link:
ADVAGEN BIOTECH https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
COVID-19 IgG/IgM LF LTDA
Brazil CORONAVIRUS For updated information on all products listed by ANVISA use this link:
COVID -19 IgG/IgM ALAMAR TECNO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Teste Rapido CIENTÍFICA LTDA - CNPJ
Brazil Panbio COVID-19 For updated information on all products listed by ANVISA use this link:
IgG/IgM Rapid Test https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Device Alere S/A
Brazil For updated information on all products listed by ANVISA use this link:
BasePoint COVID-19
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IgG/IgM
Alere S/A
Brazil ARGOSLAB For updated information on all products listed by ANVISA use this link:
Quick PROFILE DISTRIBUIDORA DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
COVID-19 IgG/IgM PRODUTOS PARA
Test Card LABORATÓRIOS LTDA
Brazil ARGOSLAB For updated information on all products listed by ANVISA use this link:
DISTRIBUIDORA DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-CoV-2 PRODUTOS PARA
(COVID19) IgM ELISA LABORATÓRIOS LTDA
Brazil ARGOSLAB For updated information on all products listed by ANVISA use this link:
DISTRIBUIDORA DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-CoV-2 PRODUTOS PARA
(COVID19) IgA ELISA LABORATÓRIOS LTDA
Brazil ARGOSLAB For updated information on all products listed by ANVISA use this link:
DISTRIBUIDORA DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-CoV-2 (COVID- PRODUTOS PARA
19) IgG ELISA LABORATÓRIOS LTDA

28
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil ARGOSLAB For updated information on all products listed by ANVISA use this link:
Quick PROFILE
DISTRIBUIDORA DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
COVID19 IgG/IgM
PRODUTOS PARA
Test Card
LABORATÓRIOS LTDA
Brazil Familia Teste de For updated information on all products listed by ANVISA use this link:
antocorpo SARS- https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
CoV-2 Arquimed Distribuidora
(immunocromatogra de Produtos Medicos -
fia - ouro colodial) Eireli - EPP
Brazil BECTON DICKINSON For updated information on all products listed by ANVISA use this link:
SARS-CoV-2 S gene INDÚSTRIAS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
for BD Max CIRÚRGICAS LTDA.
Brazil BD SARS-CoV-2 BECTON DICKINSON For updated information on all products listed by ANVISA use this link:
Reagents for BD MAX INDÚSTRIAS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
System CIRÚRGICAS LTDA.
Brazil Teste Rápido For updated information on all products listed by ANVISA use this link:
OnSite™ COVID-19 BIO ADVANCE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
IgG/IgM DIAGNOSTICOS LTDA
Brazil BIOMÉDICA For updated information on all products listed by ANVISA use this link:
Kit de Detecção por EQUIPAMENTOS E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
PCR em Tempo Real SUPRIMENTOS
VIASURE SARS-CoV-2 HOSPITALARES LTDA
Brazil BIOMERIEUX BRASIL For updated information on all products listed by ANVISA use this link:
INDUSTRIA E COMERCIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
SARS-COV-2 R-GENE
DE PRODUTOS
LABORATORIAIS LTDA
Brazil BIOMOLECULAR For updated information on all products listed by ANVISA use this link:
DIAGNOSTIC KIT FOR TECHNOLOGY COMÉRCIO, https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
NOVEL-CORONAVIRUS IMPORTAÇÃO,
(2019-NCOV) RNA (PCR- EXPORTAÇÃO E
FLUORESCENT PROBE DISTRIBUIÇÃO DE
ASSAY) MATERIAIS MÉDICOS E
LABORATORIAIS

29
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil BIOMOLECULAR For updated information on all products listed by ANVISA use this link:
TECHNOLOGY https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
NEW CORONAVIRUS COMÉRCIO,
IGG/IGM RAPID TEST IMPORTAÇÃO,
KIT (COVID-19 IgG/ EXPORTAÇÃO E
IgM)- CASSETE DISTRIBUIÇÃO DE
MATERIAIS MÉDICOS E
LABORATORIAIS LTDA
Brazil Diagnostic Kit for BIOMOLECULAR For updated information on all products listed by ANVISA use this link:
Novel- TECHNOLOGY https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Coronavirus(2019- COMÉRCIO,
nCoV) RNA IMPORTAÇÃO,
(Isothermal EXPORTAÇÃO E
Amplification-Real DISTRIBUIÇÃO DE
Time Fluorescence MATERIAIS MÉDICOS E
Assay) LABORATORIAIS LTDA
Brazil BIOMOLECULAR For updated information on all products listed by ANVISA use this link:
Diagnostic Kit for TECHNOLOGY https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
NovelCoronavirus(20 COMÉRCIO,
19nCoV) RNA IMPORTAÇÃO,
(Isothermal EXPORTAÇÃO E
Amplification-Real DISTRIBUIÇÃO DE
Time Fluorescence MATERIAIS MÉDICOS E
Assay) LABORATORIAIS LTDA -
EP
Brazil BIOMOLECULAR For updated information on all products listed by ANVISA use this link:
TECHNOLOGY https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
COMÉRCIO,
NEW CORONAVIRUS IMPORTAÇÃO,
IGG/IGM RAPID TEST EXPORTAÇÃO E
KIT (COVID-19 IgG/ DISTRIBUIÇÃO DE
IgM) MATERIAIS MÉDICOS E

30
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

LABORATORIAIS LTDA -
EPP
Brazil For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
AFIAS COVID-19 Ab Biosys LTDA
Brazil For updated information on all products listed by ANVISA use this link:
ichroma COVID-19 Ab BIOSYS LTDA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus

Brazil BRAZIL 3 BUSINESS For updated information on all products listed by ANVISA use this link:
COVID-19 Real-Time PARTICIPAÇÕES LTDA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
PCR Kit me
Brazil Celer Sansure Kit de For updated information on all products listed by ANVISA use this link:
Detecção por PCR em https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADrus
Celer biotechnologia
Tempo Real para
SARSCoV-2
Brazil For updated information on all products listed by ANVISA use this link:
One Step COVID- CELER BIOTECNOLOGIA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
2019 Test S/A
Brazil Cellex qSARSCoV-2 For updated information on all products listed by ANVISA use this link:
CELLEX, INC. – UNITED
IgG/IgM Cassette https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
STATES OF AMERICA
Rapid Test
Brazil For updated information on all products listed by ANVISA use this link:
CEPALAB https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
COVID-19 IgG/IgM LABORATÓRIOS LTDA
Brazil Cepheid Brasil For updated information on all products listed by ANVISA use this link:
Omportaçao Exportaçao https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
e Comércio de
Xpret Xpress SARS- Productos de
CoV-2 Diagnosticos ltda
Brazil For updated information on all products listed by ANVISA use this link:
DPP® COVID-19 CHEMBIO DIAGNOSTICS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgM/IgG System BRAZIL LTDA.

31
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil For updated information on all products listed by ANVISA use this link:
Asan Easy Teste
COMERCIAL JEFS LTDA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Covid19 IgG/IgM
Brazil Novel Coronavirus For updated information on all products listed by ANVISA use this link:
CPMH – Comércio e
(2019-nCoV) Nucleic https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Indústria de Produtos
Acid Detection Kit
Médico- Hospitalares e
PCR Fluorescence
Odontológicos LTDA
Probing
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM DFL INDUSTRIA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
test COMERCIO
Brazil For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
GenePro COVID-19 DFL INDÚSTRIA E
Detection Test COMÉRCIO S/A

Brazil DIAGNÓSTICA For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM INDÚSTRIA E COMÉRCIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Rapid Test LTDA
Brazil DIAGNÓSTICA For updated information on all products listed by ANVISA use this link:
CORONAVÍRUS RAPID INDÚSTRIA E COMÉRCIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
TEST LTDA
Brazil For updated information on all products listed by ANVISA use this link:
LIAISON® SARS-CoV-2
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
S1/S2 IgG
DIASORIN LTDA
Brazil SARS-CoV-2 Antibody For updated information on all products listed by ANVISA use this link:
DR IMPORTAÇÃO,
Test (colloidal gold https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
EXPORTAÇÃO E
Immunochromatograph
DISTRIBUIÇÃO LTDA
y)
Brazil For updated information on all products listed by ANVISA use this link:
CORONAVÍRUS EBRAM PRODUTOS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgG/IgM (COVID-19) LABORATORIAIS LTDA

32
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil For updated information on all products listed by ANVISA use this link:
SARS CoV-2 ECO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Detect Eco Diagnostica Ltda
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 Ag ECO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Teste Eco Diagnostica Ltda
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
ECO Teste Eco Diagnostica Ltda
Brazil For updated information on all products listed by ANVISA use this link:
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
ECO F COVID-19 Ag Eco Diagnostica Ltda
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM Eco Diagnóstica Ltda https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Combo ECO Teste
Brazil Euroimmun BRASIL For updated information on all products listed by ANVISA use this link:
EURORealTime
MEDICINA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
SARSCoV-2
DIAGNOSTICA LTDA
Brazil EUROIMMUN BRASIL For updated information on all products listed by ANVISA use this link:
Anti-SARS-CoV-2 MEDICINA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
ELISA IgA DIAGNOSTICA LTDA
Brazil EUROIMMUN BRASIL For updated information on all products listed by ANVISA use this link:
Anti-SARS-CoV-2 IgG MEDICINA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
ELISA DIAGNOSTICA LTDA
Brazil FUNDAÇÃO BAIANA DE For updated information on all products listed by ANVISA use this link:
PESQ. CIENTIFICA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DESENV. TECNOLOGICO,
FORNECIMENTO E
Teste Rápido COVID- DISTRIBUIÇÃO DE
19 IgG / IgM MEDICAMENTOS-
Bahiafarma BAHIAFARMA

33
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil Kit MOLECULAR For updated information on all products listed by ANVISA use this link:
SARS-CoV2 (E/P1) - FUNDAÇÃO OSWALDO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Bio-Manguinhos CRUZ
Brazil TR DPP® COVID-19 For updated information on all products listed by ANVISA use this link:
IGM/IGG - Bio- FUNDAÇÃO OSWALDO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Manguinhos CRUZ
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM Future Medical Eireli https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Rapid Test Kit EPP
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM GOLD ANALISA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DIAGNÓSTICA LTDA
Brazil Veri-Q PCR 316 For updated information on all products listed by ANVISA use this link:
Coronavirus disease GOYAZES BIOTECNOLOGIA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
2019(COVID-19) - LTDA
Detection Kit nCoV-QS
Brazil idoramed importação For updated information on all products listed by ANVISA use this link:
SARS-CoV-2 Antibody distribuição e comércio https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Test – Lepu de materiais médicos
Technology hospitalares eireli epp
Brazil For updated information on all products listed by ANVISA use this link:
IN VITRO DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
SARS-CoV-2 IgM/IgG LTDA
Brazil For updated information on all products listed by ANVISA use this link:
IN VITRO DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
COVID-19 IgG/IgM LTDA
Brazil For updated information on all products listed by ANVISA use this link:
n-COVID-19 IgM/IgG IN VITRO DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Ouro Coloidal LTDA
Brazil GeneFinderTM For updated information on all products listed by ANVISA use this link:
COVID19 PLUS INSTITUTO BUTANTAN https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
RealAmp Kit

34
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil For updated information on all products listed by ANVISA use this link:
KOVID ab (COVID-19 KOVALENT DO BRASIL https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgG/IgM) LTDA
Brazil For updated information on all products listed by ANVISA use this link:
DETECT SARSCoV-2 LABTEST DIAGNOSTICA
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
RT-PCR S/A
Brazil For updated information on all products listed by ANVISA use this link:
Anti COVID-19 LABTEST DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgG/IgM Rapid Test S/A
Brazil LANG E FILHOS For updated information on all products listed by ANVISA use this link:
LANG SARS-CoV-2
MATERIAL HOSPITALAR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Antibody Test
LTDA ME
Brazil TESTE RAPIDO LEVEL IMPORTAÇÃO, For updated information on all products listed by ANVISA use this link:
CORONAVÍRUS EXPORTAÇÃO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
REALY TECH COMÉRCIO S/A
Brazil LIFE TECHNOLOGIES For updated information on all products listed by ANVISA use this link:
BRASIL COMERCIO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
INDUSTRIA DE
TaqPath COVID-19 PRODUCTOS PARA
CE-IVD-RT PCR Kit BIOTECNOLOGIEA LTDA
Brazil For updated information on all products listed by ANVISA use this link:
LUMIRATEK COVID- LUMIRADX HEALTHCARE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
19 (IgG/IgM) LTDA
Brazil MANDALA BRASIL For updated information on all products listed by ANVISA use this link:
IMPORTAÇÃO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DISTRIBUIÇÃO DE
BIOSYNEX COVID-19 PRODUTO MÉDICO
BSS HOSPITALAR LTDA
Brazil Tira de Teste de For updated information on all products listed by ANVISA use this link:
Anticorpo contra MANTARAY https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
SARSCoV-2 (Método IMPORTAÇÃO E
de Ouro Coloidal) COMÉRCIO DE

35
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

PRODUTOS MÉDICOS E
CIRÚRGICOS LTDA
Brazil For updated information on all products listed by ANVISA use this link:
ALLSERUM EIA COVID
MBIOLOG https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
19 IGM
DIAGNOSTICOS LTDA
Brazil For updated information on all products listed by ANVISA use this link:
ALLSERUM EIA COVID
MBIOLOG https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
19 IGG
DIAGNOSTICOS LTDA
Brazil MEDLEVENSOHN For updated information on all products listed by ANVISA use this link:
MedTeste COMÉRCIO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Coronavírus (COVID- REPRESENTAÇÕES DE
19) IgG/IgM (TESTE PRODUTOS
RAPIDO) HOSPITALARES LTDA
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM MEDSTAR IMPORTAÇÃO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Test Cassette E EXPORTAÇÃO EIRELI
Brazil MEDTEC SUPPLIES, For updated information on all products listed by ANVISA use this link:
INDUSTRIA, https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
KIT DE TESTE RAPIDO IMPORTACAO,
PARA COVID-19 EXPORTACAO,
DISTRIBUICAO E
COMERCIO LTDA
Brazil Família KIT XGEN For updated information on all products listed by ANVISA use this link:
MASTER COVID-19 – https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Kit Master para MOBIUS LIFE SCIENCE
Detecção do INDÚSTRIA E COMERCIO
Coronavírus SARS- DE PRODUTOS PARA
CoV-2 LABORATÓRIOS LTDA
Brazil Cellex qSARSCoV-2 For updated information on all products listed by ANVISA use this link:
IgG/IgM Cassette NL COMÉRCIO EXTERIOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Rapid Test LTDA

36
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil NL qSARSCoV-2 For updated information on all products listed by ANVISA use this link:
IgG/IgM Cassette NL COMÉRCIO EXTERIOR https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Rapid Test LTDA
Brazil NL qSARS-CoV-2 For updated information on all products listed by ANVISA use this link:
NL COMÉRCIO EXTERIOR
IgG/IgM Cassette https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
LTDA
Rapid Test
Brazil NUTRIEX IMPORTACAO For updated information on all products listed by ANVISA use this link:
E EXPORTACAO DE https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Teste Rápido COVID- PRODUTOS
19 I15 minutos NUTRICIONAIS E
Nutriex FARMOQUIMICOS LTDA
Brazil SARS-CoV-2 TESTE DE For updated information on all products listed by ANVISA use this link:
ANTICORPO NUTRIMEX MEDICAL https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
(IMUNOCROMATOGR IMPORTAÇÃO E
A FIA EM OURO DISTRIBUIÇÃO LTDA
COLOIDAL)
Brazil Diagnostic Kit for For updated information on all products listed by ANVISA use this link:
IgM/IgG Antibody to OLTRAMED COMERCIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Coronavirus (SAR S- DE PRODUTOS MEDICOS
CoV-2) (Lateral Flow) LTDA
Brazil Teste para anticorpos For updated information on all products listed by ANVISA use this link:
OLTRAMED COMERCIO
de SARS-CoV-2 https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DE PRODUTOS MEDICOS
(imunocromatografia
LTDA - EPP
com ouro coloidal)
Brazil Diagnostic kit for For updated information on all products listed by ANVISA use this link:
antibody IgM/IgG of OPTME IMPORTAÇÃO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
novel coronavirus EXPORTAÇÃO DE
COVID-19 PRODUTOS LTDA – ME
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM ORBITAE DIAGNOSTICOS https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Alfa Test LTDA

37
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM ORBITAE DIAGNOSTICOS
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Assure Test LTDA
Brazil Família COVID-19 QR Consulting, For updated information on all products listed by ANVISA use this link:
IgG/IgM Teste Rápido Importação e https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
( Sangue total/ Distribuição de Produtos
Soro/Plasma) Médicos Ltda
Brazil Família Teste Rápido For updated information on all products listed by ANVISA use this link:
em Cassete 2019- QR Consulting, https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
nCoV IgG/IgM Importação e
(sangue Distribuição de Produtos
total/soro/plasma Médicos Ltda
Brazil QR Consulting, For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM Importação e https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Teste Rápido em Tira Distribuição de Produtos
Médicos Ltda
Brazil Leccurate - SARS- QUANTUM - For updated information on all products listed by ANVISA use this link:
CoV-2 Antibody Test IMPORTACAO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
(colloidal gold DISTRIBUICAO DE
immunochromatogra PRODUTOS MEDICOS
p hy) LTDA
Brazil For updated information on all products listed by ANVISA use this link:
Familia Bio GENE QUIBASA QUIMICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
COVID-19 PCR BASICA LTDA
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM QUIBASA QUIMICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
BIO BASICA LTDA
Brazil SARS-CoV-2 Antibody RENOVA MEDICAL For updated information on all products listed by ANVISA use this link:
Test (colloidal gold INDÚSTRIA E COMÉRCIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
immunochromatogra DE PRODUTOS MÉDICOS
phy) HOSPITALARES LTDA

38
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil For updated information on all products listed by ANVISA use this link:
RENYLAB QUÍMICA E
Imunotest COVID-19 https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
FARMACÊUTICA LTDA
Brazil For updated information on all products listed by ANVISA use this link:
RENYLAB QUÍMICA E
COVID-19 IgG/IgM https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
FARMACÊUTICA LTDA
Brazil For updated information on all products listed by ANVISA use this link:
Elecsys Anti-SARS- ROCHE DIAGNÓSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
CoV2 BRASIL LTDA
Brazil For updated information on all products listed by ANVISA use this link:
Família cobas® SARS- Roche Molecular https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
CoV-2 System, Inc
Brazil Casete Diagnóstico For updated information on all products listed by ANVISA use this link:
SAO JUDAS MATERIAIS
Teste de Anticorpos https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
MEDICOS LTDA
para SARS-CoV-2
Brazil SARS-CoV-2 IgG & For updated information on all products listed by ANVISA use this link:
TECMEDIC COMÉRCIO
IgM Ab Diagnostic https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DE PRODUTOS MÉDICOS
Test kit (Colloidal
LTDA
Gold)
Brazil Tekmarket Industria, For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM
comércio e servicos https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
KIT DE TESTE RÁPIDO
limitada
Brazil COVID-19 IgG/IgM For updated information on all products listed by ANVISA use this link:
Una Medic Importacao e
Rapid Test Device https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Exportação
(WB/S/P)
Brazil COVID-19 IgG/IgM For updated information on all products listed by ANVISA use this link:
Una Medic Importacao e
Rapid Test Device https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Exportação
(WB/S/P)
Brazil COVID-19 IgG/IgM UNA MEDIC For updated information on all products listed by ANVISA use this link:
Rapid Test Device IMPORTAÇAO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
(WB/S/P) EXPORTAÇAO LTDA

39
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

Brazil UNA MEDIC For updated information on all products listed by ANVISA use this link:
GeneFinder COVID- IMPORTAÇAO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
19 Plus EXPORTAÇAO LTDA
Brazil QuickProfil COVID-19 For updated information on all products listed by ANVISA use this link:
IgG/IgM Combo Test VELOZ IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Card DISTRIBUIDORA LTDA
Brazil QuickProfile COVID- For updated information on all products listed by ANVISA use this link:
Veloz Importadora e
19 IgG/IgM Combo https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Distribuidora Ltda epp
Test Card
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 VIRCLIA VIRION DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgG MONOTEST LTDA
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 VIRCLIA VIRION DIAGNOSTICA
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgM/IgA MONOTEST LTDA
Brazil For updated information on all products listed by ANVISA use this link:
SARS-COV-2 RT- PCR VIRION DIAGNOSTICA https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
KIT LTDA
Brazil For updated information on all products listed by ANVISA use this link:
VIRION DIAGNOSTICA
COVID-19 ELISA IgG https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
LTDA
Brazil For updated information on all products listed by ANVISA use this link:
COVID-19 ELISA VIRION DIAGNOSTICA
https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
IgM+IgA LTDA
Brazil VR MEDICAL For updated information on all products listed by ANVISA use this link:
COVID-19 IgG/IgM IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Rapid Test Cassette DISTRIBUIDORA DE
(WB/S/P) PRODUTOS MÉDICOS
LTD
Brazil VR MEDICAL For updated information on all products listed by ANVISA use this link:
RealStar® SARS-CoV-2
IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
RT-PCR Kit 1.0
DISTRIBUIDORA DE

40
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

PRODUTOS MÉDICOS
LTD
Brazil VR MEDICAL For updated information on all products listed by ANVISA use this link:
IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DISTRIBUIDORA DE
MAGLUMI IgG de PRODUTOS MÉDICOS
2019-nCoV (CLIA) LTDA
Brazil VR MEDICAL For updated information on all products listed by ANVISA use this link:
IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DISTRIBUIDORA DE
MAGLUMI IgM de PRODUTOS MÉDICOS
2019-nCoV (CLIA) LTDA
Brazil VR MEDICAL For updated information on all products listed by ANVISA use this link:
IMPORTADORA E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
DISTRIBUIDORA DE
AllplexTM 2019-nCoV PRODUTOS MÉDICOS
Assay LTDA
Brazil VYTTRA DIAGNOSTICOS For updated information on all products listed by ANVISA use this link:
Smart Test Covid-19 IMPORTACAO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Vyttra EXPORTACAO S.A.
Brazil W N COMÉRCIO For updated information on all products listed by ANVISA use this link:
Asan Easy Test IMPORTAÇÃO E https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
Covid19 IgG_IgM REPRESENTAÇÕES LTDA
Brazil WAMA PRODUTOS For updated information on all products listed by ANVISA use this link:
Imuno-Rápido
PARA LABORATORIO https://consultas.anvisa.gov.br/#/saude/q/?nomeTecnico=coronav%C3%ADru
COVID19 IgG/IgM
LTDA
S Korea For updated information on all products listed by the MFDS use this link:
PowerCheckTM2019- https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
kogenebiotech
nCoV RT PCR kit &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Korea AllplexTM2019-nCoV For updated information on all products listed by the MFDS use this link:
Seegene
Assay

41
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Korea For updated information on all products listed by the MFDS use this link:
DiaPlexQTMN
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Coronavirus SolGent Co.,Ltd.
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection kit
S Korea For updated information on all products listed by the MFDS use this link:
STANDARD M nCoV https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SD BIOSENSOR
RT Detection kit &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
PCLMD nCoV one &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
stop RT-PCR Kit PCL, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
LabGun™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
assay LabGenomics,
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Q-Sens 2019-nCoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
detection Kit Cancer Rop Co.,
S Korea For updated information on all products listed by the MFDS use this link:
STANDARD™Q https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
COVID-19 IgM/IgG &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Duo Test SD Biosensor,
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GeneFinder COVID- OSANG Healthcare &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
19 Plus RealAmp kit Co.,LTD

42
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
careGENE™ N-CoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
RT-PCR kit WELLS BIO, INC.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
NeoPlex™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit Genematrix Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Real-Q 2019-nCoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection kit BioSewoom, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
EzplexⓇ2019-nCoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
RTPCR Kit SML GENETREE
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SGTi-flex COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Sugentech, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SGTi-flex COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM Sugentech, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SGTi-flex COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG Sugentech, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SD BIOSENSOR
STANDARD™Q &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID-19 Ag Test

43
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SD BIOSENSOR
STANDARD™F COVID- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
19 Ag FIA
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Veri-Q PCR 316, &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
nCoV-QS MiCoBioMed,
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GenePro COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Test Gencurix Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GenBody COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG GenBody Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Humasis COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG/IgM Test Humasis Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
Dow https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
QuickFinder™2019- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
nCoV Real time PCR DowGene Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
PCL COVID19 IgG/IgM &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Rapid Gold PCL, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
PCL COVID19 Ag &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Rapid FIA PCL, Inc.

44
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
AccuPower COVID-19 https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Real-Time RT-PCR Kit &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
(NCV-1111) BIONEER Corporation
S Korea For updated information on all products listed by the MFDS use this link:
AccuPower SARS- https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
CoV-2 Real-Time RT- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
PCR Kit(SCV-2122) BIONEER Corporation
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
PaxView COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
real-time RT-PCR Kit PaxGenBio Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
AFIAS COVID-19 Ab Boditech Med
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
U-Top™2019-nCoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit SeaSun Biomaterials
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
MolecuTech® Real- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Time COVID-19 YD Diagnostics CORP.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
LiliF™COVID-19 Real- iNtRON Biotechnology, &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
time RT-PCR Kit Inc
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
1copy™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
qPCR Multi Kit 1drop Inc.

45
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
Dow QuickFinder™-G https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
2019-nCoV Real time &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
PCR DowGene Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
careGENE™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
RT-PCR kit WELLS BIO, INC.
S Korea For updated information on all products listed by the MFDS use this link:
Isopolla COVID-19 https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
detection kit(real- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
time) M monitor Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Isopolla COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
detection kit(premix) M monitor Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
iLAMP Novel-CoV19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit iONEBIO inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
BioCore 2019-nCoV &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Real Time PCR Kit BioCore Co., Ltd.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
TCM-Q Corona Ⅲ kit TCM Biosciences
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Kaira 2019-nCoV OPTOLANE Technologies &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit Inc.

46
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
RADI COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
detection kit KH Medical Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
ichroma™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Ab Boditech Med Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
AccuraDTect™SARS- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
CoV-2 RT-qPCR kit Genomictree, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
SMARTCHEK Novel https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Coronavirus (SARS- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
CoV-2)Detection Kit Genesystem Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
JD COVID-19 qRT-PCR Joonghun &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
kit Pharmaceutical Co, Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
FREND COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG/IgM Duo NanoEntek, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
WizDx™COVID-19 https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Wizbiosolutions Inc.
CrystalMix PCR Kit &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
BZ QPCR COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Kit BioZentech, Co., Ltd

47
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
BIOCREDIT COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Ag RapiGEN, INC
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
BIOCREDIT COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG+IgM Duo RapiGEN, INC
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
ExAmplar COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
real time PCR Boditech Med Inc.
S Korea For updated information on all products listed by the MFDS use this link:
PowerChcek™SARS- https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
CoV-2 Real-time PCR &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Kit KogeneBiotech Co., Ltd.
S Korea For updated information on all products listed by the MFDS use this link:
STANDARD™Q https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
COVID-19 IgM/IgG &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Combo Test SD Biosensor Inc
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Allplex™SARS-CoV-2 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Assay Seegene Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
LiliF™COVID-19 Multi iNtRON Biotechnology, &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Real-time RT-PCR Kit Inc
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Wizbiosolutions Inc.
WizDx™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Real-time PCR Kit

48
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GenePro SARS-CoV-2 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Test Gencurix Inc.
S Korea For updated information on all products listed by the MFDS use this link:
STANDARD™F COVID- https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
19 IgM/IgG Combo &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Test SD Biosensor Inc
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
U-TOP COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit SeaSun Biomaterials
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Gmate® COVID-19 Philosys Co.,Ltd.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Asan Easy Test Asan pharmaceutical &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID-19 IgG/IgM Co., LTD.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Veri-Q, nCoV-OM MiCoBioMed, Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
EU™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection Kit Eudipia
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
LabGun™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
RT-PCR Kit LabGenomics, Co., Ltd

49
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
DLP™Q COVID 19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Real Detection Kit DIOGENE Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
careUS™COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG WELLS BIO, INC.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Dr. PCR 20K COVID- &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
19 Detection Kit PRIME4DIA Co.,
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
OPTOLANE Technologies &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Axen™COVID-19 RT Inc.
S Korea For updated information on all products listed by the MFDS use this link:
Accurate Rapid https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
COVID-19 IgM/IgG &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Combo Test Macrogen, Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID19+9G test™ HUMEDIX Co,. Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
ChekR™COVID-19 Biometrix Technology, &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Rapid test Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
DIAKEY COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Rapid Test B-bio, Co., Ltd

50
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
ADTech COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG ShinJin Medics Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
CTC™Q COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Combo Test ADTceh Co., LTD
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
SsmarTest COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Detection Kit SLSBio Co., Ltd
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
AllCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgG/IgM CALTH Inc.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
NowCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
IgM/IgG Test BIONOTE, INC.
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
NowCheck COVID-19 &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Ag Test BIONOTE, INC.
S Korea GG COVID-19 For updated information on all products listed by the MFDS use this link:
Quadplex Reverse https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
Transcription Real &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Time Polymerase
Chain Reaction Kit GOODGENE Inc.
S Korea For updated information on all products listed by the MFDS use this link:
DIAKEY REALcheck https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
COVID-19(nCOV) &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
Detection kit ShinJin Medics Inc.
51
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GENEDIA W COVID- GREENCROSS MEDICAL &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
19 IgM/IgG SCIENCE
S Korea For updated information on all products listed by the MFDS use this link:
https://www.mfds.go.kr/eng/brd/m_65/view.do?seq=1&srchFr=&srchTo=&srchWord=&srchTp=
GENEDIA W ONE GREENCROSS MEDICAL &itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
COVID-19 IgM/IgG SCIENCE
China Antibody test kit for Xiamen Innodx Biotech For updated information on all products listed by the NMPA use this link:
novel coronavirus Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV
(chemiluminescence
microparticle
immunoassay)
China Antibody test kit for Guangzhou Wondfo For updated information on all products listed by the NMPA use this link:
novel coronavirus Biotech Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV
(colloidal gold
method)
China Antibody test kit for INNOVITA(Tangshan) For updated information on all products listed by the NMPA use this link:
novel coronavirus Biological Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
2019-nCoV Co., Ltd.
(colloidal gold
method)
China IgG Antibody test kit Bioscience (Chongqing) For updated information on all products listed by the NMPA use this link:
for novel Diagnostic Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (magnetic
particle-based

52
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

chemiluminescence
immunoassay)
China IgM antibody test Hecin Scientific, Inc. For updated information on all products listed by the NMPA use this link:
kit for novel https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (colloidal gold
method)
China IgM Antibody test Bioscience (Chongqing) For updated information on all products listed by the NMPA use this link:
kit for novel Diagnostic Technology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (magnetic
particle-based
chemiluminescence
immunoassay)
China IgM/IgG antibody Nanjing Vazyme Medical For updated information on all products listed by the NMPA use this link:
test kit for novel Technology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (colloidal gold
method)
China IgM/IgG antibody Zhuhai Livzon For updated information on all products listed by the NMPA use this link:
test kit for novel Diagnostics Inc. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (colloidal gold
method)
China Nucleic Acid reagent BGI For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology(Wuhan) https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (combinatorial
probe-anchor

53
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

synthesis
sequencing)
China Nucleic Acid reagent Wuhan Zhongzhi For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnologies INC. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (Dual
amplification)
China Nucleic Acid reagent Beijing Applied For updated information on all products listed by the NMPA use this link:
test kit for novel Biological Technologies https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd
nCoV (fluorometric
PCR)
China Nucleic Acid reagent BGI Biotechnology For updated information on all products listed by the NMPA use this link:
test kit for novel (Wuhan) Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Da An Gene Co., Ltd. For updated information on all products listed by the NMPA use this link
test kit for novel https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Maccura Biotechnology For updated information on all products listed by the NMPA use this link:
test kit for novel Co., Ltd.
coronavirus 2019- https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Sansure Biotech Inc. For updated information on all products listed by the NMPA use this link:
test kit for novel https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
54
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai BioGerm For updated information on all products listed by the NMPA use this link:
test kit for novel Medical Biotechnology https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai Fosun Long For updated information on all products listed by the NMPA use this link:
test kit for novel March Medical Science https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019- Co., Ltd.
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai GeneoDx For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Shanghai ZJ Bio-Tech For updated information on all products listed by the NMPA use this link:
test kit for novel Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Wuhan Easy Diagnosis For updated information on all products listed by the NMPA use this link:
test kit for novel Biomedicine Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (fluorometric
PCR)
China Nucleic Acid reagent Anbio (Xiamen) For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
55
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

nCoV (hybridization
capture
immunofluorescenc
e)
China Nucleic Acid reagent Ustar Biotechnologies For updated information on all products listed by the NMPA use this link:
test kit for novel (Hangzhou) Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (Isothermal
amplification-real
time fluorometric
PCR)
China Nucleic Acid reagent Shanghai Rendu For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (RNA capture
probe method)
China Nucleic Acid reagent Wuhan Zhongzhi For updated information on all products listed by the NMPA use this link:
test kit for novel Biotechnologies INC. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
coronavirus 2019-
nCoV (RNA
isothermal
amplification lateral
flow assay)
China Nucleic Acid reagent Chengdu CapitalBio For updated information on all products listed by the NMPA use this link:
test kit for six Biotechnology Co., Ltd. https://mp.weixin.qq.com/s/8nXlXJbE95hp0gcqsqj3Sg
respiratory viruses
(constant
temperature
amplification chip)

56
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.
Disclaimer: WHO does not endorse any of the lists provided by NRAs. This information is provided exclusively to assist stakeholders with identifying the links
to the various lists.

For updated information on all products listed by Roszdravnadzor use this link:
Russia Refer to link Refer to link
https://www.roszdravnadzor.ru/services/misearch

57
V8 This list was compiled on 25 March and was last updated on 02 June 2020. For any updates refer to the links provided in the table.