Rubella IgM EIA

SECTION 2: Hazards identification

HAZARDOUS COMPONENTS (29 CFR 1910.1200) This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. The following information is furnished for those product hazardous constituents that require regulatory control or disclosure at the concentration found in the product. The GHS, US HCS, EC CLP, and related classifications were made according to the latest editions and expanded upon from company and literature data. Refer to Section 16 for the full text of any solely abbreviated or coded hazard statements provided below. Refer to Section 16 for the Key / legend to abbreviations and acronyms. Component*

Contains

Coated Wells, - Coated wells with sonicated (inactivated) rubella antigen (strain HPV-77). [Color 12 eight-well strips ID: Yellow] Well Support, 1 Frame - No known hazardous ingredients. Diluent, - Phosphate-buffered saline with a protein stabilizer and absorbents for rheumatoid 25 mL bottle, (pink color) factor and human IgG. Catalog #25188 - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Component* Rubella IgM Calibrator 1, - Normal human serum containing high levels of rubella IgM antibody. Index value 0.5 mL vial shown on vial label. - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration Rubella IgM Calibrator 2, - Normal human serum containing moderate to low levels of rubella IgM antibody. 0.6 mL vial Index value shown on vial label. - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Rubella IgM Positive Control, - Normal human serum, Reactive for rubella IgM antibodies. Index or IU/mL values 0.6 mL vial shown on vial label. - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Rubella IgM Negative Control, - Normal human serum, Non-reactive for rubella IgM antibodies. 0.6 mL vial - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Rubella IgM Conjugate, - Goat anti-human IgM labeled with alkaline phosphatase (calf). Two (2) 12 mL bottles - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- (green color) 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Substrate, 12 mL bottle - Diluted p-Nitrophenyl phosphate [PNPP - C6H6NO6P•2Na], CAS# 4264-83-9, Catalog #25192 EC No 224-246-5. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Wash Concentrate, - Tris-buffered saline with Tween 20, pH 8.0. Not subject to GHS, US HCS, 30 mL bottle EC CLP and analogous global GHS-based regulatory requirements in this product Catalog #25190 mixture and concentration. - Preserved with 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247- 852-1. Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements without Cat 5 Acute Toxic designations in this product mixture and concentration. Stop Reagent, 12 mL bottle - 0.5M Trisodium phosphate [Na3PO4•12H2O], CAS# 10101-89-0 Catalog #25191 (Dodecahydrate). Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. * Replacement, optional, and separately purchased component Catalog numbers are provided in this column where available. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), European Community (EC) 2008/1272/EC (EC CLP) guidelines and analogous GHS- based global regulations: No Known Regulated Hazards: This product contains no hazardous constituents, or the concentrations of all chemical constituents are below the regulatory threshold limits requiring hazard communication and labeling. The information included here is in compliance with chemical hazard classification, hazard communication, and Safety Data Sheets (SDS) requirements as per the United States – Occupational Safety Health Administration Hazard Communication Standard