SAFETY DATA SHEET

Revision date 13-Apr-2021 Revision Number 1

1. Identification
Product identifier

Product Name Lyphochek Diabetes Control

Other means of identification

Catalog Number(s) 740, 740X

Recommended use of the chemical and restrictions on use

Recommended use In vitro diagnostic

Details of the supplier of the safety data sheet

Corporate Headquarters Manufacturer Address Legal Entity / Contact Address

Bio-Rad Laboratories Inc. Bio-Rad Laboratories Inc. Bio-Rad Laboratories Inc.
1000 Alfred Nobel Drive 9500 Jeronimo Road 9500 Jeronimo Road
Hercules, CA 94547 Irvine, California 92618 Irvine, California 92618
USA USA USA

Technical Service 1(800) 854-6737

[email protected]

Emergency telephone number

24 Hour Emergency Phone CHEMTREC USA: 1 (800) 424-9300

Number

2. Hazard(s) identification
Classification

This chemical is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200)

Hazards not otherwise classified (HNOC)

Not applicable

Label elements

Hazard statements
Not a hazardous substance or mixture according to the Globally Harmonized System (GHS)

The product contains no substances which at their given concentration, are considered to be hazardous to health.

Appearance powder or cake, lyophilized Physical state Solid Odor Slight

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Other information
Contains human source material and / or potentially infectious components.

3. Composition/information on ingredients
Substance

Not applicable.

Mixture

*The exact percentage (concentration) of composition has been withheld as a trade secret.

4. First-aid measures
Description of first aid measures

General advice No hazards which require special first aid measures.

Inhalation Remove to fresh air.

Eye contact Contains human source material and / or potentially infectious components. Call a
physician.

Skin contact Wash skin with soap and water.

Ingestion Call a physician. Contains human source material and / or potentially infectious
components.

Most important symptoms and effects, both acute and delayed

Symptoms No information available.

Indication of any immediate medical attention and special treatment needed

Note to physicians Contains human source material and / or potentially infectious components.

5. Fire-fighting measures
Suitable Extinguishing Media Use extinguishing measures that are appropriate to local circumstances and the
surrounding environment.

Unsuitable extinguishing media No information available.

Specific hazards arising from the None known.

chemical

Explosion data
Sensitivity to mechanical impact None.
Sensitivity to static discharge None.

Special protective equipment for Firefighters should wear self-contained breathing apparatus and full firefighting turnout
fire-fighters gear. Use personal protection equipment.

6. Accidental release measures

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Personal precautions, protective equipment and emergency procedures

Personal precautions See section 8 for more information.

Methods and material for containment and cleaning up

Methods for containment Do not allow into any sewer, on the ground or into any body of water.

Methods for cleaning up Clean contaminated surface thoroughly. Use:. Disinfectant.

7. Handling and storage

Precautions for safe handling

Advice on safe handling Handle in accordance with good industrial hygiene and safety practice.

Conditions for safe storage, including any incompatibilities

Storage Conditions Store according to product and label instructions.

8. Exposure controls/personal protection

Control parameters

Exposure Limits This product, as supplied, does not contain any hazardous materials with occupational
exposure limits established by the region specific regulatory bodies.

Appropriate engineering controls

Engineering controls Showers

Eyewash stations
Ventilation systems.

Individual protection measures, such as personal protective equipment

Eye/face protection Wear safety glasses with side shields (or goggles).

Hand protection Wear suitable gloves.

Skin and body protection Wear suitable protective clothing.

Respiratory protection No protective equipment is needed under normal use conditions. If exposure limits are
exceeded or irritation is experienced, ventilation and evacuation may be required.

General hygiene considerations Follow universal and standard precautions for handling potentially infectious materials.

9. Physical and chemical properties

Information on basic physical and chemical properties
Physical state Solid
Appearance powder or cake, lyophilized
Color red
Odor Slight
Odor threshold No information available

Property Values Remarks • Method

pH 7.95-8.05
Melting point / freezing point No data available None known

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Boiling point / boiling range No data available None known

Flash point No data available None known
Evaporation rate No data available None known
Flammability (solid, gas) No data available None known
Flammability Limit in Air None known
Upper flammability or explosive No data available
limits
Lower flammability or explosive No data available
limits
Vapor pressure No data available None known
Vapor density No data available None known
Relative density No data available None known
Water solubility Soluble in water
Solubility in other solvents No data available None known
Partition coefficient No data available None known
Autoignition temperature No data available None known
Decomposition temperature None known
Kinematic viscosity No data available None known
Dynamic viscosity No data available None known

Other information
Explosive properties Not applicable
Oxidizing properties Not applicable
Softening point Not applicable
Molecular weight Not applicable
VOC Content (%) Not applicable

10. Stability and reactivity

Reactivity No information available.

Chemical stability Stable under normal conditions.

Possibility of hazardous reactions None under normal processing.

Conditions to avoid None known based on information supplied.

Incompatible materials None known based on information supplied.

Hazardous decomposition products None known based on information supplied.

11. Toxicological information

Information on likely routes of exposure

Product Information

Inhalation Specific test data for the substance or mixture is not available.

Eye contact Specific test data for the substance or mixture is not available.

Skin contact Specific test data for the substance or mixture is not available.

Ingestion Specific test data for the substance or mixture is not available.

Symptoms related to the physical, chemical and toxicological characteristics

Symptoms No information available.

Acute toxicity
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Numerical measures of toxicity

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Skin corrosion/irritation Based on available data, the classification criteria are not met.

Serious eye damage/eye irritation Based on available data, the classification criteria are not met.

Respiratory or skin sensitization Based on available data, the classification criteria are not met.

Germ cell mutagenicity Based on available data, the classification criteria are not met.

Carcinogenicity Based on available data, the classification criteria are not met.

Reproductive toxicity Based on available data, the classification criteria are not met.

STOT - single exposure Based on available data, the classification criteria are not met.

STOT - repeated exposure Based on available data, the classification criteria are not met.

Aspiration hazard No information available.

Other adverse effects No information available.

Interactive effects No information available.

12. Ecological information

Ecotoxicity .

Persistence and degradability No information available.

Bioaccumulation There is no data for this product.

Other adverse effects No information available.

13. Disposal considerations

Waste treatment methods

Waste from residues/unused Dispose of in accordance with local regulations. Dispose of waste in accordance with
products environmental legislation.

Contaminated packaging Do not reuse empty containers.

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14. Transport information

DOT Not regulated

UN proper shipping name

TDG Not regulated

MEX Not regulated

IATA Not regulated

IMDG Not regulated

15. Regulatory information

International Inventories
Contact supplier for inventory compliance status

US Federal Regulations

SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any
chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372.

SARA 311/312 Hazard Categories

Should this product meet EPCRA 311/312 Tier reporting criteria at 40 CFR 370, refer to Section 2 of this SDS for appropriate
classifications. Under the amended regulations at 40 CFR 370, EPCRA 311/312 Tier II reporting for the 2017 calendar year will
need to be consistent with updated hazard classifications.

CWA (Clean Water Act)

This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40
CFR 122.42).

CERCLA
This material, as supplied, does not contain any substances regulated as hazardous substances under the Comprehensive
Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302) or the Superfund Amendments and
Reauthorization Act (SARA) (40 CFR 355). There may be specific reporting requirements at the local, regional, or state level
pertaining to releases of this material.

US State Regulations

California Proposition 65
This product contains the following Proposition 65 chemicals:.

Chemical name California Proposition 65

Trade secret - Developmental
Trade secret - Developmental
Trade secret - Male Reproductive

U.S. State Right-to-Know Regulations

US State Regulations This product does not contain any substances regulated by state right-to-know regulations

US State Regulations

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U.S. EPA Label Information

EPA Pesticide Registration Number Not applicable

16. Other information

NFPA Health hazards 0 Flammability 0 Instability 0 Physical and chemical
properties -
HMIS Health hazards 0 Flammability 0 Physical hazards 0 Personal protection X

Key or legend to abbreviations and acronyms used in the safety data sheet

Legend Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

TWA TWA (time-weighted average) STEL STEL (Short Term Exposure Limit)
Ceiling Maximum limit value * Skin designation

Key literature references and sources for data used to compile the SDS
Agency for Toxic Substances and Disease Registry (ATSDR)
U.S. Environmental Protection Agency ChemView Database
European Food Safety Authority (EFSA)
EPA (Environmental Protection Agency)
Acute Exposure Guideline Level(s) (AEGL(s))
U.S. Environmental Protection Agency Federal Insecticide, Fungicide, and Rodenticide Act
U.S. Environmental Protection Agency High Production Volume Chemicals
Food Research Journal
Hazardous Substance Database
International Uniform Chemical Information Database (IUCLID)
Japan GHS Classification
Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
NIOSH (National Institute for Occupational Safety and Health)
National Library of Medicine's ChemID Plus (NLM CIP)
National Library of Medicine's PubMed database (NLM PUBMED)
National Toxicology Program (NTP)
New Zealand's Chemical Classification and Information Database (CCID)
Organization for Economic Co-operation and Development Environment, Health, and Safety Publications
Organization for Economic Co-operation and Development High Production Volume Chemicals Program
Organization for Economic Co-operation and Development Screening Information Data Set
RTECS (Registry of Toxic Effects of Chemical Substances)
World Health Organization

Prepared By Bio-Rad Laboratories, Environmental Health and Safety

Revision date 13-Apr-2021

Revision Note *** Indicates this information has changed since the previous revision.
Disclaimer
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the
date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage,
transportation, disposal and release and is not to be considered a warranty or quality specification. The information
relates only to the specific material designated and may not be valid for such material used in combination with any other
materials or in any process, unless specified in the text.

End of Safety Data Sheet

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