SAFETY DATA SHEET

According to Regulation (EC) No. 1907/2006 (REACH), Annex II

This document contains SDS for the following kit components: Device

►SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE

COMPANY/UNDERTAKING
1.1 Product identifier
Trade name Panbio™ COVID-19 Ag Rapid Test Device
Reference No. 41FK10, 41FK11, 41FK20, 41FK21, 41FK31, 41FK41
Identification of the product: See section 3.
Index Number: Not available.
REACH registration NO.: Not available.

1.2 Relevant identified uses of the substance or

mixture and uses advised against
1.2.1 Identified use(s) Panbio™ COVID-19 Ag Rapid Test Device for the use as in
vitro diagnostic rapid test for the qualitative detection of
SARS-CoV-2 antigen in humans.
1.2.2 Uses advised against: Not available.
1.3 Details of the supplier of the safety data sheet
Company Identification Abbott Rapid Diagnostics Jena GmbH
Orlaweg 1
D-07743 Jena - Germany
Telephone +49-(0)3641-3111-444
E-Mail (competent person) [email protected]
1.4 Emergency telephone number
Emergency Phone No. +49-(0)3641-3111-444
EU-wide emergency number: 112

SECTION 2: HAZARDS IDENTIFICATION

2.1 Classification of the substance or mixture
2.1.1 Classification:
The mixture is classified as following according to REGULATION (EC) NO 1272/2008:

REGULATION (EC) No. 1272/2008

Hazard classes/Hazard categories Hazard codes

N/A N/A

2.2 Label elements

Hazard Pictograms No hazard Pictogram is used.
Signal Word(S) No signal word is used.
Hazard Statement Not applicable.
Precautionary Statement Not applicable.

2.3 Other hazards Not available.

►SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1 Mixtures
Description: Sodium azide
Dangerous components:

Chemical Name CAS No. EC No. REACH Classification code: Concentration

Registration Hazard Statement(s) %W/W
No.
Sodium azide -
Acute Tox. 2, H300
26628-22-8 247-852-1 Aquatic Acute 1, H400 0.01517
Aquatic Chronic 1, H410

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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

3.3 Additional Information Each device is packaged in a foil pouch.

SECTION 4: FIRST AID MEASURES

4.1 Description of first aid measures

General information No general information.

Inhalation When exposed to large amounts of steam and mist, move to
fresh air. Take specific treatment if needed.
Skin Contact Flush skin with plenty of water for at least 15 minutes while
removing contaminated clothing and shoes. Wash
contaminated clothing thoroughly before re-using.
Eye Contact Do not rub your eyes. Immediately flush eyes with plenty of
water for at least 15 minutes and call a doctor/physician.
Ingestion Please be advised by doctor whether induction of vomit is
demanded or not. Rinse your mouth with water immediately.

4.2 Most important symptoms and effects, both Not available.

acute and delayed

4.3 Indication of the immediate medical attention Notify medical personnel of contaminated situations and have
and special treatment needed them take appropriate protective measures.

SECTION 5: FIRE-FIGHTING MEASURES

5.1 Extinguishing media
Suitable Extinguishing Media Dry chemical, carbon dioxide, regular foam extinguishing
agent, spray
Unsuitable extinguishing media Avoid use of water jet for extinguishing
5.2 Special hazards arising from the substance or Not available.
mixture
5.3 Advice for fire-fighters Cool containers with water until well after fire is out. Keep
unauthorized personnel out. Withdraw immediately in case of
rising sound from venting safety devices or discoloration of
tank. Notify your local firestation and inform the location of
the fire and characteristics hazard. Keep containers cool with
water spray. Use fire fighting procedures suitable for
surrounding area.

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment

and emergency procedures
For non-emergency personnel Protective equipment: Wear proper protective equipment.
Emergency procedures: Not applicable. If required, notify
relevant authorities according to all applicable regulations.

For emergency responders

Wear proper personal protection as indicated in Section 8 and
aviod skin contact and inhalation. Must work against the wind,
let the upwind people to evacuate. Do not touch spilled
material. Stop leak if you can do it without risk. Move
container to safe area from the leak area.

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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

6.2 Environmental precautions Prevent runoff and contact with waterways, drains or sewers.
If large amounts have been spilled, inform the relevant
authorities. Avoid dispersal of spilt material and runoff and
contact with waterways, drains and sewers. If large spills,
advise emergency services.
6.3 Methods and material for containment and Don’t use a brush or compressed air for cleaning surfaces or
cleaning up clothing. Clean up all spills immediataly. No smoking, flame or
ignition sources. Stop leak if safe to do so.
Large spill: Stay upwind and keep out of low areas. Dike for
later disposal. Notify the central and local government if the
emission reaches the standard threshold. Disposal of waste
shall be in compliance with the applicable law and
regulations. Appropriate container for disposal of spilled
material collected.
Small liquid-state spills: Appropriate container for disposal of
spilled material collected. Put the spilled material in an
appropriate container and clean the contaminated area.
6.4 Reference to other sections See Section 7 for information on safe handling.
See Section 8 for information on personal protection
equipment.
See Section 13 for information on disposal.
6.5 Additional information Slippery when spilt.

SECTION 7: HANDLING AND STORAGE

7.1 Precautions for safe handling Aviod contact with incompatible materials. Handle only in a
Protective measures well-ventilated place. Do not handle until all safety
precautions have been read and understood.

Advice on general occupational

hygiene

7.2 Conditions for safe storage, including any Store in cool, dry and well ventilated place. Do not apply
incompatibilities direct heat. Store according to current laws and regulations.
Avoid direct sunlight. Prevent static electricity and keep away
from combustible materials or heat sources.

7.3 Specific end use(s) See Section 1 for information on 1.2 Relevant identified uses.

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1 Control parameters
8.1.1 Occupational Exposure Limits Not available.
8.1.2 Additional exposure limits under the Personal, workplace atmosphere or biological monitoring
conditions of use may be required to determine the effectiveness of the
ventilation or other control measures and/or the necessity to
use respiratory protective equipment.
8.1.3 DNEL/DMEL and PNEC-Values Not available.
8.2 Exposure controls
8.2.1 Appropriate engineering controls Business owner is recommended to maintain below
recommended exposure limits for the working place with
general exhaust of gas/vapour/mist/fume.

8.2.2 Personal protection equipment

Eye/face protection Wear primary eye protection such as splash resistant safety
goggles with a secondary protection face shield. Provide an
emergency eye wash station and quick drench shower in the
immediate work area.
Hand protection Wear appropriate gloves.
Body protection Skin protection: Wear appropriate clothing.
Respiratory protection Respiratory protection is ranked in order from minimum to
maximum.
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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

Consider warning properties before use.

Under conditions of frequent use or heavy exposure,
respiratory protection may be needed.
Dust, mist, fume-purifying respiratory protection.
Air-purifying respirator with high-efficiency particulate
filtering.
Any respiratory protection with a electromotion fan (for dust,
mist, fume-purifying).
Self-contained breathing apparatus with a corpuscle filter of
high efficiency.
For Unknown Concentration or Immediately Dangerous to
Life or Health: Any supplied air respirator with full facepiece
and operated in a pressure-demand or other positive
pressure mode in combination with a separate escape
supply. Any self contained breathing apparatus with a full
facepiece.

Thermal hazards No special protective equipment required.

8.2.3 Environmental Exposure Controls Do not let product enter drains. For ecological information
refer to section 12.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1 Information on basic physical and chemical
properties
Appearance Solid.

Colour Not available.

Odour Not available.
Odour Threshold (ppm) Not available.
pH (Value) Not available.
Melting Point (°C) / Freezing Point (°C) Not available.
Boiling point/boiling range (°C): Not available.
Flash Point (°C) Not available.
Evaporation rate (BA = 1) Not available.
Flammability (solid, gas) Not available.
Explosive limit ranges Not available.
Vapour Pressure (Pascal) Not available.
Vapour Density (Air=1) Not available.
Density (g/ml) Not available.
Solubility (Water) Not available.
Solubility (Other) Not available.
Partition Coefficient (n-Octanol/water) Not available.
Auto Ignition Temperature (°C) Not available.
Decomposition Temperature (°C) Not available.
Viscosity (mPa.s) Not available.
Explosive properties Not available.
Oxidising properties Not available.
Molecular Formular Not available.
Molecular Weight Not available.
9.2 Other information Not available.

SECTION 10: STABILITY AND REACTIVITY

10.1 Reactivity Not available.
10.2 Chemical stability This material is stable under recommended storage and
handling conditions.
10.3 Possibility of hazardous reactions Hazardous polymerization will not occur.

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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

10.4 Conditions to avoid Avoid the contact with ncompatible materials and condition.
Avoid the accumulation of electrostatic charges, heating,
flames and hot surfaces.
10.5 Incompatible materials Not available.
10.6 Hazardous Decomposition Product(s) May emit flammable vapour if involved in fire.

►SECTION 11: TOXICOLOGICAL INFORMATION

11.1 Information on toxicological effects
11.1.1 Substances
Not applicable.
11.2 Information on toxicological effects
Acute toxicity
LD50(Oral): Product (ATEmix) : Not available
[Water] : LD50 > 90000 mg/kg Rat (KOSHA),
[Sodium azide] : LD50 = 5 ~ 50 mg/kg

LD50(Dermal): Not available.

LC50(Inhalation): Not available.

Skin corrosion/irritation Not available.

Serious eye damage/irritation Not available.
Respiratory/skin sensitization Not available.
Germ cell mutagenicity Not available.

Carcinogenicity ACGIH: [Sodium azide]: A4

Reproductive toxicity Not available.

STOT - single exposure Not available.

STOT - repeated exposure Not available.

11.2 Other information Not available.

SECTION 12: ECOLOGICAL INFORMATION

12.1 Toxicity

Acute toxicity Time Species Evaluation Remarks

LC50 Sodium azide 96h Fish ≤1 mg/L N/A
EC50 Sodium azide 48h Invertebrate ≤1 mg/L N/A
EC50 Sodium azide 72 or 96h Algae ≤1 mg/L N/A

12.2 Persistence and degradability

12.2.1 Persistence
- [Water] : log Kow = -1.38

12.2.2 Degradability
- Not available

12.3 Bioaccumulative potential

- Not available

12.4 Mobility in soil

- Not available

12.5 Results of PBT and vPvB assessment

- Not available

12.6 Other adverse effects

- Not available

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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

SECTION 13: DISPOSAL CONSIDERATIONS

13.1 Waste treatment methods Stabilization and minimization treatment by incineration or similar
method can be applied, if more than two kinds of designated
wastes are in mixture state and it is impractical to separate them.
Oil water separation technology shall be applied as pre-waste
treatment if it is applicable. It shall be treated by incineration.
Dispose of waste in accordance with all applicable laws and
regulations.

Product/ Packaging disposal: If empty container retains product residues, all label
precautions must be observed. Dispose according to
national or local regulations.
European waste catalogue: 18 01 03.

SECTION 14: TRANSPORT INFORMATION

Land transport Sea transport Air transport

(ADR/RID) (IMDG) (ICAO/IATA)

UN-Number Not regulated Not regulated Not regulated

UN Proper shipping name Not regulated Not regulated Not regulated
Transport hazard Class Not regulated Not regulated Not regulated
Packaging group Not regulated Not regulated Not regulated
Environmental hazards No No No
Special precautions for user See section 2.2 See section 2.2 See section 2.2
Transport in bulk according to
Annex II of MARPOL 73/78 and Not regulated Not regulated Not regulated
the IBC Code

SECTION 15: REGULATORY INFORMATION

15.1 Safety, health and environmental
regulations/legislation specific for the
substance or mixture
Relevant information regarding authorization Not applicable.
Relevant information regarding restriction Not applicable.
Other EU regulations In Vitro diagnostics medical devices directive 98/79/EC.
Other National regulations Not applicable.
15.2 Chemical Safety Assessment has been carried No.
out?

►SECTION 16: OTHER INFORMATION

Indication of changes The Safety Data Sheet has been reviewed and the data therein were revised and laid out
according the requirements of the Commission Regulation (EC) No. 1907/2006

Training instructions Not applicable.

Further information The (M)SDS is a Hazard Communication tool and should be used to assist in the Risk
Assessment. Many factors determine whether the reported Hazards are Risks in the workplace
or other settings. Risks may be determined by reference to Exposures Scenarios. Scale of use,
frequency of use and current or available engineering controls must be considered. This
information is based on our current knowledge and is intended to describe the product for the
purposes of health, safety and environmental requirements only. It should not therefore be
construed as guaranteeing any specific property of the product.

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 SAFETY DATA SHEET
According to Regulation (EC) No. 1907/2006 (REACH), Annex II
This document contains SDS for the following kit components: Device

Notice to reader Employers should use this information only as a supplement to other information gathered by
them, and should make independent judgment of suitability of this information to ensure proper
use and protect the health and safety of employees. This information is furnished without
warranty, and any use of the product not in conformance with this Safety Data Sheet,or in
combination with any other product or process, is the responsibility of the user.

LEGEND

Classification code:
Acute Tox. 2 Acute toxicity, Category 2.
Aquatic Acute 1 Acute aquatic hazard. Acute 1.
Aquatic Chronic 1 Long-term aquatic hazard, Chronic 1.
LD50 Oral Median lethal dose. The dose causing 50 % lethality when given orally.
LC50 Median lethal concentration. The concentration causing 50 % lethality.
EC50 Effective concentration (50%).
ACGIH A4 American Conference of Governmental Industrial Hygienists (ACGIH) Group A4

Hazard statement(s)
H300: Fatal if swallowed.
H400: Very toxic to aquatic life.
H410: Very toxic to aquatic life with long lasting effects.

References:
Raw material safety data sheets.

Additional Information

Reason for update: Product reference numbers updated.

Supersedes: Version 3.0

Prepared by: Dr. Claudia Christner Albrecht, Email: [email protected]

To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All
materials may present unknown hazards and should be used with caution. Although certain hazards are described
herein, we cannot guarantee that these are the only hazards that exist.

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