Release Date: 5/4/20

Product Name

09N78-095 Alinity m SARS-CoV-2 AMP Kit (US EUA)

Components:
9N78P0001 Alinity m SARS-COV-2 AMP TRAY 1
09N78-090 ACT Alinity m SARS-COV-2 ACT TRAY 2
09N78-095 ACT

Abbott Customers:
For additional information, please contact your Abbott Customer Support Center Representative by calling 1-800-527-1869, 1-
800-323-9100, or 1-800-235-5396.

Abbott employees:
For additional information relative to the content of the SDSs, please contact your local Safety Representative.
 Page 1/9

Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

1 Identification
· Product name: Alinity m SARS-COV-2 AMP TRAY 1

· ADD List number: 9N78P0001

· Application of the substance / mixture: For In Vitro Diagnostic Use
· Manufacturer / Supplier:
Abbott Molecular
1300 E. Touhy Ave
Des Plaines, IL 60018-3315 USA
Tel. Abbott Molecular Customer Service: 1-800-553-7042
· Department issuing SDS: Abbott Diagnostics Environmental Health and Safety
· Emergency telephone number
Contact the CHEMTREC® Emergency Call Center for assistance with transportation or hazardous materials
emergencies (24 hours/day, 7 days/week). Refer to Abbott customer number 675834.
- Telephone (800) 424-9300 (toll-free) if you are calling from within the United States, Canada, Puerto Rico and the
Virgin Islands.
- Telephone +1 (703) 527-3887, the international and maritime number (collect calls accepted), if you are calling
from outside the United States or from a ship at sea.

2 Hazard(s) identification
· Classification of the substance or mixture
The classification was made according to U.S. OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European
regulations, and is expanded upon from supplier company and/or literature data.
Skin Sens. 1 H317 May cause an allergic skin reaction.
· Label elements
· GHS label elements: The product is labelled according to the Globally Harmonized System (GHS).
· Hazard pictograms:

· Signal word: Warning

· Hazard-determining components of labeling:
2-Methyl-4-isothiazolin-3-one
· Hazard statements:
H317 May cause an allergic skin reaction.
· Precautionary statements:
P261 Avoid breathing mist / vapors / spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P280 Wear protective gloves/protective clothing/eye protection.
P302+P352 If on skin: Wash with plenty of water.
P333+P313 If skin irritation or rash occurs: Get medical advice/attention.
P362+P364 Take off contaminated clothing and wash it before reuse.
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Safety Data Sheet

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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 AMP TRAY 1

P501 Dispose of contents / container in accordance with local regulations.

· Routes of Exposure:
Skin
For bloodborne pathogens and potentially infectious materials:
- non-intact skin
- mucous membranes (which includes, but is not limited to, the lining of the nose, mouth and throat)
- parenteral contact (e.g. by injection, puncture)
· Hazard Overview
· Health: Sensitizer in contact with skin
· Fire: Noncombustible
· Reactivity: Minimal hazard - Stable, even in a fire. Not reactive with water. Not an oxidizer.
· Other hazards
This product contains potentially infectious material. Refer to the US OSHA Bloodborne pathogens standard (29 CFR
1910.1030) for additional relevant information.

3 Composition/information on ingredients
· Chemical characterization: Mixture of chemical and/or biological substances for in vitro diagnostic use.
· Hazardous chemical ingredients per U.S. OSHA criteria (29 CFR 1910.1200 Hazard Communication):
CAS: 77-86-1 Tris hydroxymethyl aminomethane 2.42%
CAS: 56-81-5 Glycerol 1.07%
CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one 0.015%

4 First-aid measures
· General information: Immediately remove any clothing soiled by the product.
· After inhalation: Remove from source of exposure. Seek medical attention and appropriate follow-up.
· After skin contact:
Take off any clothing that the product touched. Wash affected area with soap and water. Seek medical attention and
appropriate follow-up.
· After eye contact:
Rinse open eye(s) cautiously with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. Seek medical attention and appropriate follow-up. Wash hands after handling.
· After swallowing: Rinse mouth with water. Seek medical attention and appropriate follow-up.
· Information for Medical Personnel
This product contains human sourced and/or potentially infectious components. See package insert / instructions for
use for details. No known test method can offer complete assurance that products derived from human sources or
inactivated microorganisms will not transmit infection.
· Most important symptoms and effects, both acute and delayed:
Kidney effects
Allergic reactions
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Safety Data Sheet

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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 AMP TRAY 1

Possibly immune response

This product may cause skin sensitization reactions in some people. See Section 11 for additional information.
· Medical conditions aggravated by exposure:
Pre-existing kidney ailments
Pre-existing skin ailments
Skin allergies

5 Fire-fighting measures
· Suitable extinguishing agents
Dry chemical, carbon dioxide (CO2), water spray or regular foam.
- Caution: CO2 will displace air in confined spaces and may cause an oxygen-deficient atmosphere.
- For larger fires: There are no unique chemical or reactivity hazards that would impact firefighting decisions related
to this product. Use firefighting measures that suit the environment.
· Special hazards arising from the substance or mixture
There are no unique chemical or reactivity hazards that would impact firefighting decisions due to the chemicals in this
product.
No further relevant information available.
· Protective equipment
For large fires, wear appropriate heat- and flame-resistant personal protective equipment and a NFPA/NIOSH
approved positive-pressure, self-contained breathing apparatus.

* 6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures
Handle as a potentially infectious material.
Minimize exposure by using appropriate personal protective equipment as listed in Section 8. Stop leak if possible.
Keep unprotected persons away.
· Environmental precautions
Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up
Blot up small volumes of spilled or spattered product with paper towels or similar materials.
- Contain larger spills by placing absorbants around the outside edges of the spill. Absorb with any material suitable
for water-based liquids - e.g. paper towels, universal sorbents, sand, diatomite, sawdust, etc.
Clean the affected area. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Apply a suitable disinfectant. Select a disinfectant that is effective against bloodborne infectious agents, as well as
other microbial agents that you might expect to be prevalent in your population. A disinfectant that is effective against
Mycobacterium tuberculosis is generally effective against all known viruses and non-sporeforming bacteria, and is
suitable for most clinical laboratory situations.

NOTE: Commercial disinfectants must be used according to manufacturer directions. Disinfectants are typically
hazardous chemicals that react with many chemicals, materials and living tissues. Obtain and review the
manufacturer’s safety information before using the disinfectant.
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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 AMP TRAY 1

Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section
13 for information that may impact disposal of materials contaminated with this product.
· 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 disposal information.

* 7 Handling and storage

· Precautions for safe handling:
Handle as a potentially infectious material.
Avoid contact with skin.
· Information about protection against explosions and fires: The product is not flammable.
· Requirements to be met by storerooms and receptacles: Store only in the original container.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions:
Refer to the package insert or product label for additional information on storage conditions for product quality.

8 Exposure controls/personal protection

· Components with Occupational Exposure Limits
The following constituents are the only constituents of the product which have a PEL, TLV or other recommended
exposure limit.
At this time, the other constituents have no known exposure limits.
CAS: 56-81-5 Glycerol (1.07 %)
PEL TWA: 15* 5** mg/m³
mist; *total dust **respirable fraction
TLV TLV withdrawn-insufficient data human occup. exp.
CAS: 7647-01-0 hydrochloric acid (0.02 %)
PEL Ceiling limit value: 7 mg/m³, 5 ppm
REL Ceiling limit value: 7 mg/m³, 5 ppm
TLV Ceiling limit value: 2.98 mg/m³, 2 ppm
· General protective and hygienic measures:
Always maintain good housekeeping and follow general precautionary measures. Do not eat, drink or store food
and beverages in areas where chemicals or specimens are used. Wash hands before breaks, after handling
reagents and specimens, and at the end of the workshift.
Observe universal precautions and other appropriate biosafety practices for handling potentially infectious material.
Avoid contact with the skin.
Immediately remove all soiled and contaminated clothing.
· Breathing equipment:
Normal use and storage of product - respiratory protection is not necessary if room is well ventilated.

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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 AMP TRAY 1

Small-volume spills (e.g. small enough to clean up with a paper towel or small sorbent pad) - respiratory protection
should not be necessary if room is well ventilated.

Other unusual conditions (e.g. volume spilled too big to clean up with materials in arm's reach) - Use appropriate
NIOSH-approved air-purifying respirator if airborne chemical concentrations may exceed the exposure limit (if any)
listed above.

Hazardous Materials Emergencies or Firefighting - use NIOSH/NFPA-approved respiratory protection.

· Hand protection:
Wear impervious gloves if hand contact with the material is anticipated. Dispose of contaminated gloves after use in
accordance with applicable laws and good laboratory practices.
· Material of gloves and breakthrough time of the glove material:
The glove material must be suitable for use in a microbiological laboratory and have a measured breakthrough
time of at least 30 minutes, such as those with a Class 2 protection index per EN374 (or equivalent standard
applicable in your region). NOTE: This recommendation applies only to the product stated in this Safety Data
Sheet. When dissolving in or mixing with other substances, contact the supplier of approved gloves.
· Eye protection:
Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective
clothing required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

* 9 Physical and chemical properties

· General Information
· Form: Liquid
· Color: Colorless
· Odor: Odorless
· pH-value Not determined
· Melting point/Melting range: Not determined
· Boiling point/Boiling range: Not determined
· Flash point Not applicable
· Auto igniting Product is not self-igniting.
· Danger of explosion Product does not present an explosion hazard.
· Explosion limits
· Lower: Not determined
· Upper: Not determined
· Density at 20 °C (68 °F) 1.011-1.019 g/cm³ (8.4368-8.5036 lbs/gal)
· Evaporation rate: Not determined
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Safety Data Sheet

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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 AMP TRAY 1

· Solubility in / Miscibility with

· Water: Fully miscible
· Dynamic: Not determined
· Water: 96.1 %

10 Stability and reactivity

· Thermal decomposition / conditions to be avoided
No decomposition if used and stored according to specifications.
· Possibility of hazardous reactions: No dangerous reactions known.
· Conditions to avoid: No further relevant information available.
· Incompatible materials: No further relevant information available.
· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity
· LD50/LC50 values for hazardous ingredients per OSHA criteria:
· Ingredients (100% pure substance/s):
CAS: 77-86-1 Tris hydroxymethyl aminomethane
Oral LD50 5,900 mg/kg (rat)
LDLo 1,000 mg/kg (rabbit)
CAS: 56-81-5 Glycerol
Oral LD50 4,090 mg/kg (mammal)
TDLo (Other effects) 1,428 mg/kg (human)
Reported headaches, nausea and vomiting.
Dermal LD50 >10,000 mg/kg (rabbit)
Inhalation LC50 1 h 0.57 mg/l (Rat)
Mutagenicity (Ames Assay)
CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one
Oral LD50 60 mg/kg (mouse)
By analogy to methylchloroisothiazolinone.
53 mg/kg (rat)
By analogy to methylchloroisothiazolinone.
· Primary toxicological effects of the final product:
· Skin irritation: No irritant effect.
· Eye irritation: No irritant effect.
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Product name: Alinity m SARS-COV-2 AMP TRAY 1

· Sensitization: Sensitization possible through skin contact.

· Additional toxicological information: None
· Carcinogenic categories
· IARC (International Agency for Research on Cancer)
None of the ingredients is listed.
· NTP (National Toxicology Program)
None of the ingredients is listed.
· OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.
· Target organs/systems:
Kidneys
Skin
Immune system

12 Ecological information
· Aquatic toxicity:
CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one
LC50 96 h 0.19 mg/l (trout) (Flow through)
LC50 48 h (Static) 0.056 mg/l (other) (Crustacean - Acartia tonsa)
· Additional ecological information
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system.
· Results of PBT and vPvB assessment
· PBT: Not applicable
· vPvB: Not applicable

13 Disposal considerations
· Recommendation for disposal of unused product:
Dispose in accordance with federal, state and local regulations and institutional requirements. The following may
be particularly important when identifying appropriate disposal:
- Potentially infectious. See Section 4, Information for Medical Personnel, for more information.
- See Section 6 for information when institutional or regulatory requirements include any sort of treatment of
potentially infectious waste.
· Recommendation for disposal of packaging:
Non-contaminated packaging may be used for recycling. Refer to applicable local regulations and institutional
policies.
For disposal of contaminated packaging, refer to applicable local regulations and institutional policies.
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Product name: Alinity m SARS-COV-2 AMP TRAY 1

· Recommended cleansing agent: Water with cleansing agents, if necessary.

14 Transport information
· DOT, ADN, IMDG, IATA none
· UN proper shipping name
· DOT, ADN, IMDG, IATA none
· Transport hazard class(es)
· DOT, ADN, IMDG, IATA
· Class none
· DOT, IMDG, IATA none
· Environmental hazards
· Marine pollutant: No
· Additional information
· DOT
· Remarks: Not restricted for transportation.
· IMDG
· Remarks: Not restricted for transportation.
· IATA
· Remarks: Not restricted for transportation.

15 Regulatory information
· SARA (Superfund Amendments and Reauthorization Act of 1986 - USA):
· Section 302/304 (40CFR355.30 / 40CFR355.40):
CAS: 7647-01-0 hydrochloric acid
· Section 313 (40CFR372.65):
CAS: 7647-01-0 hydrochloric acid
· Hazardous Air Pollutants
CAS: 7647-01-0 hydrochloric acid
· California Proposition 65 (USA):
· Chemicals known to cause cancer:
The product does not contain listed substances.
· Chemicals known to cause female reproductive toxicity:
None of the ingredients is listed.
· Chemicals known to cause male reproductive toxicity:
None of the ingredients is listed.
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Product name: Alinity m SARS-COV-2 AMP TRAY 1

· Chemicals known to cause developmental reproductive toxicity:

None of the ingredients is listed.

16 Other information
The information and recommendations contained herein are based upon information or tests believed to be reliable.
Abbott Laboratories does not guarantee the accuracy or completeness of this information or recommendations
contained herein, NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER
EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR
THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.

This information is not a substitute for the advice of a health care professional, nor is it a recommendation for any
particular course of treatment. It is not intended to supplement, modify or supersede any information (e.g. labeling and
package inserts) provided with respect to the medical use of the product. Abbott Laboratories assumes no
responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use
of these data. No warranty against infringement of any patent, copyright or trademark is made or implied.
· Department issuing SDS
- Abbott Diagnostics Safety, Health and Environmental Assurance
Department 0571
· Contact
Tel. Abbott Molecular Customer Service: 1-800-553-7042
- General information about this product:
Abbott Diagnostics
Technical Support
100 Abbott Park Road
Abbott Park, IL 60064-3500

Phone: 1-877-4 ABBOTT

· Date of preparation / last revision 05/04/2020 / 1
· Abbreviations and acronyms:
IMDG: International Maritime Code for Dangerous Goods
DOT: US Department of Transportation
IATA: International Air Transport Association
EINECS: European Inventory of Existing Commercial Chemical Substances
ELINCS: European List of Notified Chemical Substances
CAS: Chemical Abstracts Service (Division of the American Chemical Society)
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
OSHA: Occupational Safety & Health
TLV: Threshold Limit Value
PEL: Permissible Exposure Limit
REL: Recommended Exposure Limit
Skin Sens. 1: Skin sensitisation – Category 1

· * Sections marked with an asterisk (*) have been altered since the previous version.
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1 Identification
· Product name: Alinity m SARS-COV-2 ACT TRAY 2

· ADD List number:

09N78-090 ACT
09N78-095 ACT
· Application of the substance / mixture: For In Vitro Diagnostic Use
· Manufacturer / Supplier:
Abbott Molecular
1300 E. Touhy Ave
Des Plaines, IL 60018-3315 USA
Tel. Abbott Molecular Customer Service: 1-800-553-7042
· Department issuing SDS: Abbott Diagnostics Environmental Health and Safety
· Emergency telephone number
Contact the CHEMTREC® Emergency Call Center for assistance with transportation or hazardous materials
emergencies (24 hours/day, 7 days/week). Refer to Abbott customer number 675834.
- Telephone (800) 424-9300 (toll-free) if you are calling from within the United States, Canada, Puerto Rico and the
Virgin Islands.
- Telephone +1 (703) 527-3887, the international and maritime number (collect calls accepted), if you are calling
from outside the United States or from a ship at sea.

* 2 Hazard(s) identification
· Classification of the substance or mixture
The classification was made according to U.S. OSHA 29 CFR 1910.1200 and 1910.1030 and applicable European
regulations, and is expanded upon from supplier company and/or literature data.
Acute Tox. 4 H302 Harmful if swallowed.
Skin Sens. 1 H317 May cause an allergic skin reaction.
STOT SE 1 H370 Causes damage to organs.
Aquatic Chronic 3 H412 Harmful to aquatic life with long lasting effects.
· Label elements
· GHS label elements: The product is labelled according to the Globally Harmonized System (GHS).
· Hazard pictograms:

· Signal word: Danger

· Hazard-determining components of labeling:
Tetramethylammonium chloride
2-Methyl-4-isothiazolin-3-one
· Hazard statements:
H302 Harmful if swallowed.
H317 May cause an allergic skin reaction.
H370 Causes damage to organs.
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Product name: Alinity m SARS-COV-2 ACT TRAY 2

H412 Harmful to aquatic life with long lasting effects.

· Precautionary statements:
P260 Do not breathe mist / vapors / spray.
P264 Wash hands thoroughly after handling.
P272 Contaminated work clothing should not be allowed out of the workplace.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection.
P301+P312 If swallowed: Call a poison center/doctor if you feel unwell.
P302+P352 If on skin: Wash with plenty of water.
P308+P311 IF exposed or concerned: Call a poison center/doctor.
P333+P313 If skin irritation or rash occurs: Get medical advice/attention.
P362+P364 Take off contaminated clothing and wash it before reuse.
P501 Dispose of contents / container in accordance with local regulations.
· Routes of Exposure: Skin
· Hazard Overview
· Health:
Sensitizer in contact with skin
Harmful if swallowed
· Fire: Noncombustible
· Reactivity: Minimal hazard - Stable, even in a fire. Not reactive with water. Not an oxidizer.

3 Composition/information on ingredients
· Chemical characterization: Mixture of chemical and/or biological substances for in vitro diagnostic use.
· Hazardous chemical ingredients per U.S. OSHA criteria (29 CFR 1910.1200 Hazard Communication):
CAS: 75-57-0 Tetramethylammonium chloride 8.71%
CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one 0.015%

4 First-aid measures
· General information: Immediately remove any clothing soiled by the product.
· After inhalation: Remove from source of exposure. If irritation or signs of toxicity occur, seek medical attention.
· After skin contact:
Take off any clothing that the product touched.
Rinse skin with running water for 15 to 20 minutes. Seek medical attention if irritation or signs of toxicity occur.
· After eye contact:
Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists, get medical advice/attention. Wash hands after handling.
· After swallowing: Rinse mouth with water. If irritation or signs of toxicity occur, seek medical attention.
· Information for Medical Personnel
· Most important symptoms and effects, both acute and delayed:
Allergic reactions
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Safety Data Sheet

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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

Possibly immune response

This product may cause skin sensitization reactions in some people. See Section 11 for additional information.
· Medical conditions aggravated by exposure:
Pre-existing skin ailments
Skin allergies

5 Fire-fighting measures
· Suitable extinguishing agents
Dry chemical, carbon dioxide (CO2), water spray or regular foam.
- Caution: CO2 will displace air in confined spaces and may cause an oxygen-deficient atmosphere.
- For larger fires: There are no unique chemical or reactivity hazards that would impact firefighting decisions related
to this product. Use firefighting measures that suit the environment.
· Special hazards arising from the substance or mixture
There are no unique chemical or reactivity hazards that would impact firefighting decisions due to the chemicals in this
product.
No further relevant information available.
· Protective equipment
For large fires, wear appropriate heat- and flame-resistant personal protective equipment and a NFPA/NIOSH
approved positive-pressure, self-contained breathing apparatus.

6 Accidental release measures

· Personal precautions, protective equipment and emergency procedures
Minimize exposure by using appropriate personal protective equipment as listed in Section 8. Stop leak if possible.
Keep unprotected persons away.
· Environmental precautions
Prevent liquid and vapor from entering sewage system, storm drains, surface waters, and soil.
· Methods and material for containment and cleaning up
Blot up small volumes of spilled or spattered product with paper towels or similar materials.
- Contain larger spills by placing absorbants around the outside edges of the spill. Absorb with any material suitable
for water-based liquids - e.g. paper towels, universal sorbents, sand, diatomite, sawdust, etc.
Clean the affected area. Suitable cleaners are:
- warm water and detergent or similar cleansing agent
Dispose of spilled and contaminated material in accordance with Federal, State, and Local regulations. See Section
13 for information that may impact disposal of materials contaminated with this product.
· 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 disposal information.
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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

7 Handling and storage

· Precautions for safe handling: Avoid contact with skin.
· Information about protection against explosions and fires: The product is not flammable.
· Requirements to be met by storerooms and receptacles: Store only in the original container.
· Information about storage in one common storage facility: Store in original packaging.
· Further information about storage conditions:
Refer to the package insert or product label for additional information on storage conditions for product quality.

8 Exposure controls/personal protection

· Components with Occupational Exposure Limits
The product does not contain any hazardous ingredients with occupational exposure limits established by OSHA,
ACGIH, or NIOSH.
· General protective and hygienic measures:
Always maintain good housekeeping and follow general precautionary measures. Do not eat, drink or store food
and beverages in areas where chemicals or specimens are used. Wash hands before breaks, after handling
reagents and specimens, and at the end of the workshift.
Avoid contact with the skin.
Immediately remove all soiled and contaminated clothing.
· Breathing equipment:
Normal use and storage of product - respiratory protection is not necessary if room is well ventilated.

Small-volume spills (e.g. small enough to clean up with a paper towel or small sorbent pad) - respiratory protection
should not be necessary if room is well ventilated.

Other unusual conditions (e.g. volume spilled too big to clean up with materials in arm's reach) - Use appropriate
NIOSH-approved air-purifying respirator if airborne chemical concentrations may exceed the exposure limit (if any)
listed above.

Hazardous Materials Emergencies or Firefighting - use NIOSH/NFPA-approved respiratory protection.

· Hand protection:
Wear impervious gloves if hand contact with the material is anticipated. Dispose of contaminated gloves after use in
accordance with applicable laws and good laboratory practices.
· Material of gloves and breakthrough time of the glove material:
The glove material must be suitable for use in a microbiological laboratory and have a measured breakthrough
time of at least 30 minutes, such as those with a Class 2 protection index per EN374 (or equivalent standard
applicable in your region). NOTE: This recommendation applies only to the product stated in this Safety Data
Sheet. When dissolving in or mixing with other substances, contact the supplier of approved gloves.
· Eye protection:
Wear safety glasses or other protective eyewear. If splash potential exists, wear full face shield or goggles.
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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

· Body protection:
Normal use: protect personal clothing from spatters and small spills. Wear a laboratory coat (or other protective
clothing required by your institution).
Larger spills (e.g. that can saturate cloth): wear appropriate water-repellant covering over clothing.

9 Physical and chemical properties

· General Information
· Form: Liquid
· Color: Colorless
· Odor: Odorless
· pH-value at 20 °C (68 °F) 6.25
· Melting point/Melting range: Not determined
· Boiling point/Boiling range: Not determined
· Flash point Not applicable
· Flammability (solid, gaseous) Not applicable
· Auto igniting Product is not self-igniting.
· Danger of explosion Product does not present an explosion hazard.
· Explosion limits
· Lower: Not determined
· Upper: Not determined
· Density at 20 °C (68 °F) 1.007 g/cm³ (8.4034 lbs/gal)
· Evaporation rate: Not determined
· Solubility in / Miscibility with
· Water: Fully miscible
· Dynamic: Not determined
· Water: 90.8 %

10 Stability and reactivity

· Thermal decomposition / conditions to be avoided
No decomposition if used and stored according to specifications.
· Possibility of hazardous reactions: No dangerous reactions known.
· Conditions to avoid: No further relevant information available.
· Incompatible materials: No further relevant information available.
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Safety Data Sheet

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© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information
· Acute toxicity
· LD50/LC50 values for hazardous ingredients per OSHA criteria:
· Ingredients (100% pure substance/s):
CAS: 75-57-0 Tetramethylammonium chloride
Oral LD50 50 mg/kg (rat)
National Technical Information Service. Vol. OTS0536975
Sources cited: Toxicological Data, compiled by the National Institute of Health (NIH), USA, selected and
distributed by Technical Database Services (TDS), New York, 2009
CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one
Oral LD50 60 mg/kg (mouse)
By analogy to methylchloroisothiazolinone.
53 mg/kg (rat)
By analogy to methylchloroisothiazolinone.
· Primary toxicological effects of the final product:
· Skin irritation: No irritant effect.
· Eye irritation: No irritant effect.
· Sensitization: Sensitization possible through skin contact.
· Additional toxicological information: None
· Carcinogenic categories
· IARC (International Agency for Research on Cancer)
None of the ingredients is listed.
· NTP (National Toxicology Program)
None of the ingredients is listed.
· OSHA-Ca (Occupational Safety & Health Administration)
None of the ingredients is listed.
· Target organs/systems:
Skin
Immune system

12 Ecological information
· Aquatic toxicity:
CAS: 75-57-0 Tetramethylammonium chloride
LC50 96 h 462 mg/l (minnow)
Source cited: Ecotoxicological Data, compiled by the US Environmental Protection Agency (EPA),
selected and distributed by Technical Database Services (TDS), New York, 2009
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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

CAS: 2682-20-4 2-Methyl-4-isothiazolin-3-one

LC50 96 h 0.19 mg/l (trout) (Flow through)
LC50 48 h (Static) 0.056 mg/l (other) (Crustacean - Acartia tonsa)
· Additional ecological information
· General notes:
Do not allow undiluted product or large quantities of it to reach ground water, water course, or sewage system.
Harmful to aquatic organisms.
· Results of PBT and vPvB assessment
· PBT: Not applicable
· vPvB: Not applicable

13 Disposal considerations
· Recommendation for disposal of unused product:
Dispose in accordance with federal, state and local regulations.
· Recommendation for disposal of packaging:
Non-contaminated packaging may be used for recycling. Refer to applicable local regulations and institutional
policies.
For disposal of contaminated packaging, refer to applicable local regulations and institutional policies.
· Recommended cleansing agent: Water with cleansing agents, if necessary.

14 Transport information
· DOT, ADN, IMDG, IATA none
· UN proper shipping name
· DOT, ADN, IMDG, IATA none
· Transport hazard class(es)
· DOT, ADN, IMDG, IATA
· Class none
· DOT, IMDG, IATA none
· Environmental hazards
· Marine pollutant: No
· Additional information
· DOT
· Remarks: Not restricted for transportation.
· IMDG
· Remarks: Not restricted for transportation.
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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

· IATA
· Remarks: Not restricted for transportation.

15 Regulatory information
· SARA (Superfund Amendments and Reauthorization Act of 1986 - USA):
· Section 302/304 (40CFR355.30 / 40CFR355.40):
The product does not contain listed substances.
· Section 313 (40CFR372.65):
The product does not contain listed substances.
· Hazardous Air Pollutants
None of the ingredients is listed.
· California Proposition 65 (USA):
· Chemicals known to cause cancer:
The product does not contain listed substances.
· Chemicals known to cause female reproductive toxicity:
None of the ingredients is listed.
· Chemicals known to cause male reproductive toxicity:
None of the ingredients is listed.
· Chemicals known to cause developmental reproductive toxicity:
None of the ingredients is listed.

16 Other information
The information and recommendations contained herein are based upon information or tests believed to be reliable.
Abbott Laboratories does not guarantee the accuracy or completeness of this information or recommendations
contained herein, NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER
EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR
THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE.

This information is not a substitute for the advice of a health care professional, nor is it a recommendation for any
particular course of treatment. It is not intended to supplement, modify or supersede any information (e.g. labeling and
package inserts) provided with respect to the medical use of the product. Abbott Laboratories assumes no
responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use
of these data. No warranty against infringement of any patent, copyright or trademark is made or implied.
· Department issuing SDS
- Abbott Diagnostics Safety, Health and Environmental Assurance
Department 0571
· Contact
Tel. Abbott Molecular Customer Service: 1-800-553-7042
- General information about this product:
Abbott Diagnostics
Technical Support
USA

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Safety Data Sheet

according to OSHA Hazard Communication standard 29CFR 1910.1200
© Abbott Laboratories Release date 05/04/2020 Last alteration on 04/28/2020

Product name: Alinity m SARS-COV-2 ACT TRAY 2

100 Abbott Park Road

Abbott Park, IL 60064-3500

Phone: 1-877-4 ABBOTT

· Date of preparation / last revision 05/04/2020 / 1
· Abbreviations and acronyms:
IMDG: International Maritime Code for Dangerous Goods
DOT: US Department of Transportation
IATA: International Air Transport Association
EINECS: European Inventory of Existing Commercial Chemical Substances
ELINCS: European List of Notified Chemical Substances
CAS: Chemical Abstracts Service (Division of the American Chemical Society)
LC50: Lethal concentration, 50 percent
LD50: Lethal dose, 50 percent
PBT: persistent, bioaccumulative and toxic
vPvB: very persistent and very bioaccumulative
OSHA: Occupational Safety & Health
TLV: Threshold Limit Value
PEL: Permissible Exposure Limit
REL: Recommended Exposure Limit
Acute Tox. 4: Acute toxicity – Category 4
Skin Sens. 1: Skin sensitisation – Category 1
STOT SE 1: Specific target organ toxicity (single exposure) – Category 1
Aquatic Chronic 3: Hazardous to the aquatic environment - long-term aquatic hazard – Category 3

· * Sections marked with an asterisk (*) have been altered since the previous version.
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