1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

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1 MATERIAL SAFETY DATA SHEET according to EC Directive 2001/58/EC ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Product Type Negative Control/Sample Diluent Product Name ImmunoCard STAT! CAMPY Negative Control/Sample Diluent Catalogue Number(s) NC/SD Manufacturer, importer, supplier Meridian Bioscience, Inc River Hills Drive, Cincinnati, OH U.S.A. (513) EMERGENCY TELEPHONE CHEMTREC: NUMBER INTERNATIONAL EMERGENCY CHEMTREC: TELEPHONE NUMBER AUTHORIZED Meridian Bioscience Europe Via dell' Industria 7 REPRESENTATIVE Villa Cortese Milano, Italy INTENDED USE: In Vitro Diagnostic Medical Device Chemical nature of the preparation 2. COMPOSITION/INFORMATION ON INGREDIENTS CAS Chemical Name % Weight Classification: EINECS* Chaps 2.50 N/A N/A Sodium chloride 0.88 N/A Sodium azide 0.09 T+ N; R28 R32 R50 R Gentamicin, sulfate (salt) N/A * EINECS - EINECS For the full text of the R phrases mentioned in this Section, see Section HAZARDS IDENTIFICATION Classification: Most important hazards Not dangerous 4. FIRST AID MEASURES General advice Show this safety data sheet to the doctor in attendance Avoid contact with skin, eyes and clothing Skin contact Wash off immediately with soap and plenty of water Eye contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes If eye irritation persists, seek medical attention Inhalation: Move to fresh air. If exposure symptoms persist, seek medical attention. Ingestion: Do not swallow. Rinse mouth with water and afterwards drink plenty of water. Never give anything by mouth to an unconscious person Consult a physician if necessary Notes to physician Treat symptomatically 5. FIRE-FIGHTING MEASURES ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent The Wercs Ltd. Page 1 of 4

2 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent Flash point N/D Suitable extinguishing media carbon dioxide (CO2) water spray alcohol-resistant foam dry chemical Extinguishing media which must not be used for safety reasons Special protective equipment for firefighters As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear Specific methods 6. ACCIDENTAL RELEASE MEASURES Personal precautions Environmental precautions Methods for cleaning up Ensure adequate ventilation No special environmental precautions required Absorb spill with inert material (e.g. dry sand or earth), then place in a chemical waste container After cleaning, flush away traces with water 7. HANDLING AND STORAGE Handling Safe handling advice Storage Technical measures/precautions Incompatible products Store in a tightly closed container. Store in a cool, dry, well ventilatied area away from incompatible substances. Keep in properly labelled containers. Occupational exposure controls 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Engineering measures Exposure Limit Values Ensure adequate ventilation, especially in confined areas. As a rule, at least 10 air changes per hour are recommended at the workplace. CAS Chemical Name % Weight ACGIH* FOEL* EUOED* Chaps 2.50 N/A N/A N/A Sodium chloride 0.88 N/A N/A N/A Sodium azide 0.09 N/A N/A 0.1 mg/m3 TWA Gentamicin, sulfate (salt) N/A N/A N/A * ACGIH - Occupational Exposure Limits - TWAs * FOEL - France Occupational Exposure Limits - TWA's (VME's) * EUOED - EU Occupational Exposure Directive (98/24/EC) Indicative Occupational Exposure Limit Values (IOELV) Personal protective equipment Respiratory protection Hand protection Eye protection Skin and body protection Hygiene measures Avoid inhalation of vapors. Wear appropriate protective gloves Wear tightly fitting safety goggles or safety glasses with side-shields Light weight protective clothing to protect exposed skin Handle in accordance with good industrial hygiene and safety practice Keep away from food, drink and animal feeding stuffs ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent The Wercs Ltd. Page 2 of 4

3 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent Environmental exposure controls 9. PHYSICAL AND CHEMICAL PROPERTIES General Information Form Liquid. Colour Odour Important Health Safety and Environmental Information ph Boiling point/range N/D Flash point N/D Water solubility Soluble. 10. STABILITY AND REACTIVITY Stability Conditions to avoid Materials to avoid Hazardous decomposition products Polymerization Stable under normal conditions. Extremes of temperature and direct sunlight None under normal use. Polymerization does not occur. 11. TOXICOLOGICAL INFORMATION Acute toxicity Component Information Product Information LD50/dermal/rat = LD50/oral/rat = Chronic toxicity carcinogenic effects mutagenic effects Reproductive toxicity Target Organ Effects 12. ECOLOGICAL INFORMATION Component Information CAS Chemical Name % Weight ACGIH* Chaps 2.50 N/A Sodium chloride 0.88 N/A Sodium azide 0.09 N/A Gentamicin, sulfate (salt) N/A * ACGIH - Occupational Exposure Limits - TWA's Ecotoxicity effects 13. DISPOSAL CONSIDERATIONS Waste from residues / unused products In accordance with local and national regulations. ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent The Wercs Ltd. Page 3 of 4

4 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent Contaminated packaging Further information Empty containers should be rinsed and disposed of as appropriate for glass and plastic containers. 14. TRANSPORT INFORMATION Not classified as dangerous in the meaning of transport regulations 15. REGULATORY INFORMATION Contains Indication of danger R -phrase(s) S -phrase(s) Not dangerous International Inventories DSL - CAS Chemical Name % Weight TSCA* EINECS* ENCS* Canada* Chaps 2.50 N/A N/A N/A N/A Sodium chloride 0.88 Present Present Sodium azide 0.09 Present Present Gentamicin, sulfate (salt) N/A N/A * TSCA - United States - Section 8 (b) Inventory (TSCA) * EINECS - EINECS * DSL - Canada - Domestic Substances List (DSL) * ENCS - Japan Existing and New Chemical Substances (ENCS) Text of R phrases mentioned in Section OTHER INFORMATION R28 - Very toxic if swallowed. R32 - Contact with acids liberates very toxic gas. R53 - May cause long-term adverse effects in the aquatic environment. R50 - Very toxic to aquatic organisms. Prepared on: 2009/01/06 The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Meridian Bioscience, Inc. shall no be held liable for any damages resulting from handling or from contact with the above product. End of Safety Data Sheet ImmunoCard STAT! CAMPY Negative Control/ Sample Diluent The Wercs Ltd. Page 4 of 4

5 MATERIAL SAFETY DATA SHEET according to EC Directive 2001/58/EC ImmunoCard STAT! CAMPY Positive Control IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Product Type Positive Control Product Name ImmunoCard STAT! CAMPY Positive Control Catalogue Number(s) PC Manufacturer, importer, supplier Meridian Bioscience, Inc River Hills Drive, Cincinnati, OH U.S.A. (513) EMERGENCY TELEPHONE CHEMTREC: NUMBER INTERNATIONAL EMERGENCY CHEMTREC: TELEPHONE NUMBER AUTHORIZED Meridian Bioscience Europe Via dell' Industria 7 REPRESENTATIVE Villa Cortese Milano, Italy INTENDED USE: In Vitro Diagnostic Medical Device Chemical nature of the preparation 2. COMPOSITION/INFORMATION ON INGREDIENTS CAS Chemical Name % Weight Classification: EINECS* Sodium chloride 0.86 N/A Sodium azide 0.09 T+ N; R28 R32 R50 R Gentamicin, sulfate (salt) N/A * EINECS - EINECS For the full text of the R phrases mentioned in this Section, see Section HAZARDS IDENTIFICATION Classification: Most important hazards Not dangerous 4. FIRST AID MEASURES General advice Show this safety data sheet to the doctor in attendance Avoid contact with skin, eyes and clothing Skin contact Wash off immediately with soap and plenty of water Eye contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes If eye irritation persists, seek medical attention Inhalation: Move to fresh air. If exposure symptoms persist, seek medical attention. Ingestion: Do not swallow. Rinse mouth with water and afterwards drink plenty of water. Never give anything by mouth to an unconscious person Consult a physician if necessary Notes to physician Treat symptomatically 5. FIRE-FIGHTING MEASURES Flash point N/D ImmunoCard STAT! CAMPY Positive Control Ltd. The Wercs Page 1 of 4

6 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Positive Control Suitable extinguishing media Extinguishing media which must not be used for safety reasons Special protective equipment for firefighters Specific methods carbon dioxide (CO2) water spray alcohol-resistant foam dry chemical As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear 6. ACCIDENTAL RELEASE MEASURES Personal precautions Environmental precautions Methods for cleaning up Ensure adequate ventilation No special environmental precautions required Absorb spill with inert material (e.g. dry sand or earth), then place in a chemical waste container After cleaning, flush away traces with water 7. HANDLING AND STORAGE Handling Safe handling advice Storage Technical measures/precautions Incompatible products Store in a tightly closed container. Store in a cool, dry, well ventilatied area away from incompatible substances. Keep in properly labelled containers. Occupational exposure controls 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Engineering measures Exposure Limit Values Ensure adequate ventilation, especially in confined areas. As a rule, at least 10 air changes per hour are recommended at the workplace. CAS Chemical Name % Weight ACGIH* FOEL* EUOED* Sodium chloride 0.86 N/A N/A N/A Sodium azide 0.09 N/A N/A 0.1 mg/m3 TWA Gentamicin, sulfate (salt) N/A N/A N/A * ACGIH - Occupational Exposure Limits - TWAs * FOEL - France Occupational Exposure Limits - TWA's (VME's) * EUOED - EU Occupational Exposure Directive (98/24/EC) Indicative Occupational Exposure Limit Values (IOELV) Personal protective equipment Respiratory protection Hand protection Eye protection Skin and body protection Hygiene measures Environmental exposure controls Avoid inhalation of vapors. Wear appropriate protective gloves Wear tightly fitting safety goggles or safety glasses with side-shields Light weight protective clothing to protect exposed skin Handle in accordance with good industrial hygiene and safety practice Keep away from food, drink and animal feeding stuffs ImmunoCard STAT! CAMPY Positive Control Ltd. The Wercs Page 2 of 4

7 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Positive Control PHYSICAL AND CHEMICAL PROPERTIES General Information Form Liquid. Colour Odour Important Health Safety and Environmental Information ph Boiling point/range N/D Flash point N/D Water solubility Soluble. 10. STABILITY AND REACTIVITY Stability Conditions to avoid Materials to avoid Hazardous decomposition products Polymerization Stable under normal conditions. Extremes of temperature and direct sunlight None under normal use. Polymerization does not occur. 11. TOXICOLOGICAL INFORMATION Acute toxicity Component Information Product Information LD50/dermal/rat = LD50/oral/rat = Chronic toxicity carcinogenic effects mutagenic effects Reproductive toxicity Target Organ Effects 12. ECOLOGICAL INFORMATION Component Information CAS Chemical Name % Weight ACGIH* Sodium chloride 0.86 N/A Sodium azide 0.09 N/A Gentamicin, sulfate (salt) N/A * ACGIH - Occupational Exposure Limits - TWA's Ecotoxicity effects 13. DISPOSAL CONSIDERATIONS Waste from residues / unused products Contaminated packaging Further information In accordance with local and national regulations. Empty containers should be rinsed and disposed of as appropriate for glass and plastic containers. ImmunoCard STAT! CAMPY Positive Control Ltd. The Wercs Page 3 of 4

8 MATERIAL SAFETY DATA SHEET ImmunoCard STAT! CAMPY Positive Control TRANSPORT INFORMATION Not classified as dangerous in the meaning of transport regulations 15. REGULATORY INFORMATION Contains Indication of danger R -phrase(s) S -phrase(s) Not dangerous International Inventories CAS Chemical Name % Weight TSCA* EINECS* DSL - Canada* ENCS* Sodium chloride 0.86 Present Present Sodium azide 0.09 Present Present Gentamicin, sulfate (salt) N/A N/A * TSCA - United States - Section 8 (b) Inventory (TSCA) * EINECS - EINECS * DSL - Canada - Domestic Substances List (DSL) * ENCS - Japan Existing and New Chemical Substances (ENCS) Text of R phrases mentioned in Section OTHER INFORMATION R28 - Very toxic if swallowed. R32 - Contact with acids liberates very toxic gas. R53 - May cause long-term adverse effects in the aquatic environment. R50 - Very toxic to aquatic organisms. Prepared on: 2009/01/06 The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Meridian Bioscience, Inc. shall no be held liable for any damages resulting from handling or from contact with the above product. End of Safety Data Sheet ImmunoCard STAT! CAMPY Positive Control Ltd. The Wercs Page 4 of 4

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