BAX System PCR Tablets

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1 This SDS adheres to the standards and regulatory requirements of the United States and may not meet the regulatory requirements in other countries. SECTION 1. PRODUCT AND COMPANY IDENTIFICATION Product name : Product Grade/Type : BAX Sample Tablet, Yeast & Mold; Genus Listeria; Listeria mono; E. coli O157:H7 MP; Salmonella; Salmonella 2 E. coli O157:H7 MP; L. monocytogenes 24E; Enterobacter Sakazakii; Genus Listeria 24E; Genus Listeria; Real-Time Campylobacter; Real-Time E. coli O157:H7; Real-Time Genus Listeria; Real-Time Listeria Monocytogenes Real-Time Staphylococcus aureus; Real-Time Shigella Real-Time Shigella; Real-Time Vibrio; Real-Time STEC Panel 1 E. coli O26, O111, O121 Real-Time STEC Panel 2 E. coli O45, O103, O145; Real-Time STEC Screening stx and eae Item Number : Refer to Section 16. Product Use : For professional users only. Restrictions on use : Do not use product for anything outside of the above specified uses Manufacturer/Supplier : Qualicon Diagnostics LLC A Hygiena Company 200 Powder Mill Road Wilmington, DE Product Information : SECTION 2. HAZARDS IDENTIFICATION Not classified as a hazardous substance or mixture according to the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard Other hazards No applicable data available. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS-No. Concentration Inert Ingredients Not applicable >99% SECTION 4. FIRST AID MEASURES General advice Inhalation Skin contact : No hazards which require special first aid measures. : No specific intervention is indicated as the compound is not likely to be hazardous. Consult a physician if necessary. : The material is not likely to be hazardous by skin contact, but cleaning the skin after use is advisable. Consult a physician if necessary. 1 / 5

2 Eye contact Ingestion Most important symptoms/effects, acute and delayed Protection of first-aiders Notes to physician : Hold eye open and rinse slowly and gently with water for minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye. Consult a physician if necessary. : Is not considered a potential route of exposure. Consult a physician if necessary. SECTION 5. FIREFIGHTING MEASURES Suitable extinguishing media Unsuitable extinguishing media Specific hazards Special protective equipment for firefighters Further information : Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. : Not a fire or explosion hazard. : Standard procedure for chemical fires.evacuate personnel to safe areas. SECTION 6. ACCIDENTAL RELEASE MEASURES NOTE: Review FIRE FIGHTING MEASURES and HANDLING (PERSONNEL) sections before proceeding with clean-up. Use appropriate PERSONAL PROTECTIVE EQUIPMENT during clean-up. Safeguards (Personnel) Environmental precautions Spill Cleanup Accidental Release Measures : No special precautions required. : Shovel or sweep up. : Follow applicable Federal, State/Provincial and Local laws/regulations. SECTION 7. HANDLING AND STORAGE Handling (Personnel) Handling (Physical Aspects) Dust explosion class Storage Storage period Storage temperature : Avoid contact with skin, eyes and clothing. NO HAZARDS FOUND. USE GOOD INDUSTRIAL PRACTICES. : Keep refrigerated. : 4 C (39 F) 2 / 5

3 SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Engineering controls Personal protective equipment Eye protection Skin and body protection Exposure Guidelines Exposure Limit Values Inert Ingredients No applicable data available. : Use only with adequate ventilation. : Safety glasses : Wear protective clothing such as gloves, apron, boots, or coveralls, as appropriate. SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance Physical state Form Color Odor Odor threshold ph Melting point/range Boiling point/boiling range Flash point Evaporation rate Flammability (solid, gas) Upper explosion limit Lower explosion limit Vapour Pressure Vapour density Specific gravity (Relative density) Water solubility Solubility(ies) Partition coefficient: n- octanol/water : solid : tablet : white Auto-ignition temperature Decomposition temperature Viscosity, kinematic Viscosity, dynamic 3 / 5

4 SECTION 10. STABILITY AND REACTIVITY Reactivity Chemical stability : Stable under normal conditions. Possibility of hazardous reactions : Polymerization will not occur. Conditions to avoid Incompatible materials Hazardous decomposition products SECTION 11. TOXICOLOGICAL INFORMATION Further information : no data available Carcinogenicity The carcinogenicity classifications for this product and/or its ingredients have been determined according to HazCom 2012, Appendix A.6. The classifications may differ from those listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or those found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest edition). None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, or OSHA, as a carcinogen. SECTION 12. ECOLOGICAL INFORMATION Additional ecological information : no data available SECTION 13. DISPOSAL CONSIDERATIONS Waste disposal methods - Product Contaminated packaging : Treatment, storage, transportation, and disposal must be in accordance with applicable federal, state/provincial, and local regulations. SECTION 14. TRANSPORT INFORMATION Not regulated in transportation by DOT/IMO/IATA. SECTION 15. REGULATORY INFORMATION SARA 313 Regulated Chemical(s) California Prop. 65 : This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313. : Chemicals known to the State of California to cause cancer, birth defects or any other harm: none known 4 / 5

5 SECTION 16. OTHER INFORMATION Yeast & Mold Genus Listeria Listeria mono BAX Sample Tablet (Continued from Section 1) Item Number ASY2051 (D ) ASY2048 (D ) ASY2049 (D ) E. coli O157:H7 MP ASY2046 (D ) Salmonella Salmonella 2 Genus Listeria 24E ASY2050 (D ) ASY2058 (D ) ASY2052 (D ) L. monocytogenes 24E ASY2053 (D ) Cronobacter (Enterobacter Sakazakii) Real-Time Campylobacter Real-Time E. coli O157:H7 Real-Time Genus Listeria Real-Time Listeria Monocytogenes Real-Time Staphylococcus aureus Real-Time Shigella Real-Time Vibrio Real-Time STEC Panel 1 E. coli O26, O111, O121 Real-Time STEC Panel 2 E. coli O45, O103, O145 Real-Time STEC Screening stx and eae X5 E. coli O157:H7 X5 L. monocytogenes PACKAGE - TABLETS - REAL TIME SHIGELLA - 48 X5 Genus Listeria X5 Salmonella ASY2047 (D ) ASY2045 (D ) ASY2057 (D ) ASY2060 (D ) ASY2055 (D ) ASY2061 (D ) ASY2056 (D ) ASY2059 (D ) ASY2062 (D ) ASY2063 (D ) ASY2064 (D ) ASY2066 (D ) ASY2067 (D ) ASY2068 (D ) ASY2069 (D ) Trademark of Qualicon Diagnostics LLC Registered trademark of Qualicon Diagnostics LLC 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. Significant change from previous version is denoted with a double bar. 5 / 5