Material Safety Data Sheet
Revision date:
Print Date: 07/27/2007
Version: 0
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: KIT COBAS T-SCRN WNV CONTROL US-IVD
Product number: 04741749190
Business area: Molecular Diagnostics.
Supplier: Emergency telephone number:
Roche Molecular Systems, Inc. CHEMTREC:
1080 US Highway 202 South 1-800-424-9300 (U.S. or Canada)
Branchburg, NJ 08876-3733 1-703-527-3887 (International)
Technical Support: 1-800-526-1247
2. COMPOSITION/INFORMATION ON INGREDIENTS
Description 1: Negative Control
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Human plasma NONE 99-100 NA NA NA NA
Description 2: Positive Control
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
No hazardous components >1%, NONE N/A NA NA NA NA
>0.1% carcinogen
3. HAZARDS IDENTIFICATION
Emergency Overview
NFPA Ratings:
Negative Control Health= 1 Flammability= 0 Reactivity= 0 Special= PB
Positive Control Health= 0 Flammability= 0 Reactivity= 0
Special Definitions: A=Allergen CA=Carcinogen CO=Corrosive F=Flammable H=Harmful I=Irritant Ox=Oxidizer PB=Potential Biohazard
R=Reproductive S=Sensitizer T=Toxic T+=Highly Toxic W=Water Reactive
Principle routes of exposure: Ingestion, skin and/or eye contact
Inhalation: None
Ingestion: Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea
Skin contact: None
Eye contact: Contact with eyes may cause irritation
Sensitization or Odor threshold: The following chemical(s) may cause sensitization, be absorbed via skin, and/or has an odor threshold for
detection:
Medical conditions aggravated by None known
exposure:
Additional information: With FDA approved methods, the human source material in this product has been tested and is shown to
be free from HBsAg and antibodies to HCV and HIV. All human material should be considered potentially
infectious. It is recommended to handle this product in accordance with Universal Precautions and the
OSHA Bloodborne Pathogen Standard (29CFR1910.1030).
4. FIRST AID MEASURES
Inhalation: Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
give oxygen
Skin contact: Rinse with plenty of water. If skin irritation persists, call a physician. Remove and wash contaminated
clothing before re-use
Ingestion: Consult a physician. Do not induce vomiting without medical advice
Eye contact: In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice
Notes to physician: None determined
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media: Use dry chemical, CO2, water spray or `alcohol` foam
Unusual hazards: None known
Special protective equipment for Wear self contained breathing apparatus for fire fighting if necessary
firefighters:
6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Use personal protective equipment. Evacuate personnel to safe areas
Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent product from entering drains.
Methods for cleaning up: Never return spills in original containers for re-use. Sweep up or vacuum (if powder) or soak up with inert
absorbent material (if liquid), then place into a suitable clean, dry, closed container, and label for disposal
7. HANDLING AND STORAGE
Handling: For human source material, handle as if containing infectious material. Protect from contamination. Wear personal
protective equipment.
Storage: No special precautions required
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Not applicable
Personal Protective Equipment
Respiratory protection: Respiratory protection is not required under normal use of this product. If respiratory protection is needed,
follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary
Hand protection: Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly
Skin and body protection: Wear appropriate body protection to prevent skin contact
Eye protection: Wear appropriate eye protection to prevent eye contact
Hygiene measures: Avoid contact with skin, eyes and clothing
9. PHYSICAL AND CHEMICAL PROPERTIES
Color: Negative Control = yellow. Positive Control = colorless.
Odor: None.
pH: Positive Control = 8. Negative Control = neutral.
Physical state: Liquid.
Solubility in water: Soluble.
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: Carbon oxides
Materials to avoid: Strong acids and strong bases. Strong oxidising agents
11. TOXICOLOGICAL INFORMATION
Inhalation: No additional data available
Skin: No additional data available
Oral: No additional data available
Mutagenic effects: No data is available on the product itself
Reproductive toxicity: No data is available on the product itself
Carcinogenic effects:
Product number: 04741749190 Page 2 of 3
Product name: KIT COBAS T-SCRN WNV CONTROL US-IVD
12. ECOLOGICAL INFORMATION
Bioaccumulation: Not determined
Aquatic toxicity: No data is available on the product itself
Ecotoxicity effects: No data is available on the product itself
13. DISPOSAL CONSIDERATIONS
Waste from residues / unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product,
if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local
hazardous waste regulatory authority. Residue from fires extinguished with this material may be
hazardous
14. TRANSPORT INFORMATION
Is product hazardous to ship? No
DOT
Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable
ICAO/IATA
Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable
15. REGULATORY INFORMATION
U.S. Regulations:
U.S. CERCLA/SARA/TSCA Regulatory Information: The following chemicals are listed under the following TSCA/SARA/CERCLA lists. Refer to
TSCA regulation if you need a definition for acronyms that may be shown in the TSCA Inventory field in the table below
U.S. Clean Water Act (CWA)/ California The following chemicals are listed under the CWA and/or California Proposition 65:
Proposition 65:
Canadian Regulations:
Canada DSL Inventory List - This product does not comply with DSL
Canada NDSL Inventory List - This product does not comply with NDSL
16. OTHER INFORMATION
Reason for revision: Not applicable
References: None
Additional advice: None
Prepared by: Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505
The information, data and recommendations contained herein are based upon information believed by Roche Diagnostics Corporation, after reasonable investigation and
research, to be accurate; however, Roche Diagnostics Corporation does not warrant the accuracy of this information. All materials and mixtures may present unknown
hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained
professionals. Roche Diagnostics Corporation disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular
purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Roche Diagnostics
Corporation's option. In no case shall Roche Diagnostics Corporation be liable for incidental or consequential damages, including lost profits.
End of Safety Data Sheet
Product number: 04741749190 Page 3 of 3
Product name: KIT COBAS T-SCRN WNV CONTROL US-IVD
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