FACTOR Xa Reagent

US/CANADA

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

General Information

Version

01

Product name

FACTOR Xa Reagent

1.2.1 Relevant identified uses

For in vitro diagnostic use

1.2.2. Uses advised against

Other uses are not expected

Manufacturer Name

US/CANADA

Emergency telephone

+44 (0) 3700 492 795, +1 215 ...

Icons in SDS

GHS08 M004 M009 M010 M011

Company Information

company name

US/CANADA

e-mail address of the competent person responsible for the Safety Data Sheet

infosds@werfen.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H334

Hazard statements

Code

Statements

H334

May cause allergy or asthma symptoms or breathing difficulties if inhaled

Section 2

SECTION 2: Hazards identification

WHMIS 2015 Classification of the substance or mixture

Signal word

Danger

Hazard statements

May cause allergy or asthma symptoms or breathing difficulties if inhaled

Precautionary statements

Avoid breathing vapours, dust. Wear respiratory protection. . If inhaled: Remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a POISON CENTER, a doctor. Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 2.3. Hazards associated with known or reasonably anticipated uses No additional information available

Other hazards which do not result in classification

None. Warning: The product contains bovine material. All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem health inspection by a veterinarian, and they were apparently free from infectious and contagious material. However, the material should be treated as potentially infectious. Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma symptoms or breathing difficulties if inhaled. 2.5. Unknown acute toxicity No additional information available

2.1 Classification of the substance or mixture

amendment and adjustments Respiratory sensitization, Category 1 May cause allergy or asthma symptoms or breathing difficulties if inhaled. 2.2. Label elements Labelling according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015) and their subsequent amendments and adjustments Hazard pictograms (GHS US) : Signal word (GHS US) : Danger Hazard statements (GHS US) : May cause allergy or asthma symptoms or breathing difficulties if inhaled Precautionary statements (GHS US) : Avoid breathing vapours, dust. Wear respiratory protection. . If inhaled: Remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a POISON CENTER, a doctor. Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation. 2.3. Hazards associated with known or reasonably anticipated uses No additional information available 2.4. Hazards not otherwise classified Other hazards which do not result in classification : None. Warning: The product contains bovine material. All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem health inspection by a veterinarian, and they were apparently free from infectious and contagious material. However, the material should be treated as potentially infectious. Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma symptoms or breathing difficulties if inhaled. 2.5. Unknown acute toxicity No additional information available SECTION 3 Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Comments : Composition: liquid containing organic and inorganic components, bovine source material. Name Product Conc. % Classification 29 CFR 1910.1200 (HCS) HPR identifier w/w * (WHMIS 2015) Factor Xa - < 1.5 Eye damage/Eye Irritation, cat. 2A Specific target organ Toxicity – Single Exposure, cat. 3 Skin Corrosion/Irritation, cat. 2 Sensitization-Respiratory, cat. 1 Pyridine-2-thiol 1-oxide, sodium salt; pyrithione CAS-No.: 3811- < 0.02 Acute Toxicity – Oral, cat. 4 sodium; sodium pyrithione 73-2

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