GS HBsAg Confirmatory Assay 3.0

SECTION 2: Hazards identification

HAZARDOUS COMPONENTS 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. Refer to Section 16 for the full text of any solely abbreviated or coded

Hazard statements

provided below and for the Key / legend to abbreviations and acronyms Component

Contains

1 Antibody to Hepatitis - Antibody to HBsAg (Human), non-reactive for HBsAg, and antibody to HCV, HIV-1 and HIV-2. B Surface Antigen - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- (Human) (HBsAg one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous Confirmatory Reagent), global GHS-based regulatory requirements in this product mixture and concentration. 1 vial (1.0 mL) - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. 2 HBsAg Negative - Normal human serum, non-reactive for HBsAg, anti-HBsAg and antibodies to HIV and HCV. Control (Human), - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- 1 bottle (12 mL) one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), and European Community (EC) 2008/1272/EC (EC CLP) guidelines and analogous GHS-based global regulations: The chemical dilutions in this product are not subject to classification or labeling according to United Nations (UN) GHS, United States Hazard Communication Standard (US HCS), related European Community (EC) 2008/1272/EC (EC CLP) guidelines and applicable analogous GHS-based global regulations.