Reagent R1, Reagent R2, Calibrators and Controls

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Date of issue: 06/15/2015 Date of Revision: 06/23/2015 Revision: B SECTION 1 Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form Product name Product code Mixture Cardiac Troponin Reagent R1, Reagent R2, Calibrators and Controls DZ145A DZ145A-R1, DZ145A-R2, DZ145A-CAL, DZ145A-CON 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet Supplier: Diazyme Laboratories 12889 Gregg Court Poway, CA 92064 T 858-455-4768 Authorized Representative: MDSS GmbH Schiffgraben 41 Germany (+49) 511-6262-8630 1.4. Emergency telephone number Emergency number Contact your local health authority or poison control center in an emergency. Manufacturer contact number for the US is as follows: (858) 455-4768 SECTION 2 Hazards identification 2.1. Classification of the substance or mixture Classification (GHS-US) Flam. Liq. 2 H225 Full text of H-phrases: see section 16 2.2. Label elements GHS-US labeling Hazard pictograms (GHS-US) Signal word (GHS-US) Hazard statements (GHS-US) Precautionary statements (GHS-US) Danger GHS02 H225 - Highly flammable liquid and vapor P210 - Keep away from heat/sparks/open flames/hot surfaces. - No smoking P233 - Keep container tightly closed P240 - Ground/bond container and receiving equipment P241 - Use explosion-proof electrical/ventilating/lighting/ equipment P242 - Use only non-sparking tools P243 - Take precautionary measures against static discharge P280 - Wear protective gloves/protective clothing/eye protection/face protection P303+P361+P353 - If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower P370+P378 - In case of fire: Use... to extinguish P403+P235 - Store in a well-ventilated place. Keep cool P501 - Dispose of contents/container to... 2.3. Other hazards 06/15/2015 SDS 1072 Rev B EN (English US) Page 1

2.4. Unknown acute toxicity (GHS-US) SECTION 3 Composition/information on ingredients 3.1. Substance 3.2. Mixture Full text of H-phrases: see section 16 SECTION 4 First aid measures 4.1. Description of first aid measures First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion Remove person to fresh air and keep comfortable for breathing. Rinse skin with water/shower. Remove/Take off immediately all contaminated clothing. Rinse eyes with water as a precaution. Call a poison center/doctor/physician if you feel unwell. 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed Treat symptomatically. SECTION 5 Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Water spray. Dry powder. Foam. Carbon dioxide. 5.2. Special hazards arising from the substance or mixture Fire hazard Highly flammable liquid and vapor. Reactivity Highly flammable liquid and vapor. 5.3. Advice for firefighters Protection during firefighting Do not attempt to take action without suitable protective equipment. Self-contained breathing apparatus. Complete protective clothing. SECTION 6 Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures 6.1.1. For non-emergency personnel Emergency procedures 6.1.2. For emergency responders Protective equipment Ventilate spillage area. No open flames, no sparks, and no smoking. Do not attempt to take action without suitable protective equipment. For further information refer to section 8: "Exposure controls/personal protection". 6.2. Environmental precautions Avoid release to the environment. 6.3. Methods and material for containment and cleaning up Methods for cleaning up Take up liquid spill into absorbent material. Notify authorities if product enters sewers or public waters. Other information Dispose of materials or solid residues at an authorized site. 6.4. Reference to other sections For further information refer to section 13. SECTION 7 Handling and storage 7.1. Precautions for safe handling Precautions for safe handling Hygiene measures Ensure good ventilation of the work station. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Ground/bond container and receiving equipment. Use only nonsparking tools. Take precautionary measures against static discharge. Flammable vapors may accumulate in the container. Use explosion-proof equipment. Wear personal protective equipment. Do not eat, drink or smoke when using this product. Always wash hands after handling the product. 06/15/2015 SDS 1072 Rev B EN (English US) 2/1

7.2. Conditions for safe storage, including any incompatibilities Technical measures Storage conditions 7.3. Specific end use(s) SECTION 8 Exposure controls/personal protection 8.1. Control parameters Cardiac Troponin ACGIH Ground/bond container and receiving equipment. Store in a well-ventilated place. Keep cool. Keep container tightly closed. OSHA 8.2. Exposure controls Appropriate engineering controls Hand protection Eye protection Skin and body protection Respiratory protection Environmental exposure controls Ensure good ventilation of the work station. Protective gloves. Safety glasses. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory equipment. Avoid release to the environment. SECTION 9 Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state Color Odor Odor threshold ph Melting point Freezing point Boiling point Flash point Relative evaporation rate (butyl acetate=1) Flammability (solid, gas) Explosion limits Explosive properties Oxidizing properties Vapor pressure Relative density Relative vapor density at 20 C Liquid Mixture contains one or more component(s) which have the following colour(s): Colourless There may be no odour warning properties, odour is subjective and inadequate to warn of overexposure. Mixture contains one or more component(s) which have the following odour(s): Characteristic odour Mild odour Pleasant odour Alcohol odour Commercial/unpurified substance: Irritating/pungent odour Solubility Water Solubility in water of component(s) of the mixture : : >= 100 g/100ml Log Pow Log Kow Auto-ignition temperature Decomposition temperature Viscosity Viscosity, kinematic Viscosity, dynamic 06/15/2015 SDS 1072 Rev B EN (English US) 3/1

9.2. Other information SECTION 10 Stability and reactivity 10.1. Reactivity Highly flammable liquid and vapor. 10.2. Chemical stability Stable under normal conditions. 10.3. Possibility of hazardous reactions No dangerous reactions known under normal conditions of use. 10.4. Conditions to avoid Avoid contact with hot surfaces. Heat. No flames, no sparks. Eliminate all sources of ignition. 10.5. Incompatible materials 10.6. Hazardous decomposition products Under normal conditions of storage and use, hazardous decomposition products should not be produced. SECTION 11 Toxicological information 11.1. Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard SECTION 12 Ecological information 12.1. Toxicity Ecology - general The product is not considered harmful to aquatic organisms or to cause long-term adverse effects in the environment. 12.2. Persistence and degradability 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Other adverse effects Effect on the global warming No known ecological damage caused by this product. SECTION 13 Disposal considerations 13.1. Waste treatment methods Waste treatment methods Additional information Dispose of contents/container in accordance with licensed collector s sorting instructions. Flammable vapors may accumulate in the container. 06/15/2015 SDS 1072 Rev B EN (English US) 4/1

SECTION 14 Transport information Department of Transportation (DOT) In accordance with DOT Transport document description UN1230 Methanol, 3, II UN-No.(DOT) UN1230 Proper Shipping Name (DOT) Methanol Transport hazard class(es) (DOT) 3 - Class 3 - Flammable and combustible liquid 49 CFR 173.120 Hazard labels (DOT) 3 - Flammable liquid Packing group (DOT) DOT Packaging Non Bulk (49 CFR 173.xxx) 202 DOT Packaging Bulk (49 CFR 173.xxx) 242 DOT Symbols DOT Special Provisions (49 CFR 172.102) DOT Packaging Exceptions (49 CFR 173.xxx) 150 DOT Quantity Limitations Passenger aircraft/rail (49 CFR 173.27) DOT Quantity Limitations Cargo aircraft only (49 CFR 175.75) DOT Vessel Stowage Location DOT Vessel Stowage Other II - Medium Danger D - Proper shipping name for domestic use only, or to and from Canada IB2 - Authorized IBCs: Metal (31A, 31B and 31N); Rigid plastics (31H1 and 31H2); Composite (31HZ1). Additional Requirement: Only liquids with a vapor pressure less than or equal to 110 kpa at 50 C (1.1 bar at 122 F), or 130 kpa at 55 C (1.3 bar at 131 F) are authorized. T7-4 178.274(d)(2) Normal... 178.275(d)(3) TP2 - a. The maximum degree of filling must not exceed the degree of filling determined by the following: (image) Where: tr is the maximum mean bulk temperature during transport, tf is the temperature in degrees celsius of the liquid during filling, and a is the mean coefficient of cubical expansion of the liquid between the mean temperature of the liquid during filling (tf) and the maximum mean bulk temperature during transportation (tr) both in degrees celsius. b. For liquids transported under ambient conditions may be calculated using the formula: (image) Where: d15 and d50 are the densities (in units of mass per unit volume) of the liquid at 15 C (59 F) and 50 C (122 F), respectively. 1 L 60 L B - (i) The material may be stowed on deck or under deck on a cargo vessel and on a passenger vessel carrying a number of passengers limited to not more than the larger of 25 passengers, or one passenger per each 3 m of overall vessel length; and (ii) On deck only on passenger vessels in which the number of passengers specified in paragraph (k)(2)(i) of this section is exceeded. 40 - Stow clear of living quarters Additional information Other information No supplementary information available. ADR Transport by sea UN-No. (IMDG) 1230 Proper Shipping Name (IMDG) METHANOL Class (IMDG) 3 - Flammable liquids Packing group (IMDG) II - substances presenting medium danger Air transport UN-No. (IATA) 1230 Proper Shipping Name (IATA) Methanol Class (IATA) 3 - Flammable Liquids Packing group (IATA) II - Medium Danger 06/15/2015 SDS 1072 Rev B EN (English US) 5/1

SECTION 15 Regulatory information 15.1. US Federal regulations 15.2. International regulations CANADA EU-Regulations Classification according to Regulation (EC) No. 1272/2008 [CLP] Flam. Liq. 2 H225 Full text of H-phrases: see section 16 Classification according to Directive 67/548/EEC [DSD] or 1999/45/EC [DPD] National regulations 15.3. US State regulations SECTION 16 Other information Full text of H-phrases ------ Flam. Liq. 2 Flammable liquids Category 2 ------ H225 Highly flammable liquid and vapor SDS US Diazyme This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product 06/15/2015 SDS 1072 Rev B EN (English US) 6/1