THYROID STIMULATING HORMONE (TSH) ELISA

SECTION 2: Hazards identification

2.1 POTENTIAL BIOHAZARD: The Calibrator and Controls are formulated with a buffer base, animal serum, and human serum. The human serums are tested by a United States Food and Drug Administration (USFDA) licensed method and found to be non-reactive for HIV-1, HIV-2, Hepatitis B surface antigen and HCV. Because no test method can offer absolute assurance that these agents are absent, reagents should be handled at the Biosafety Level 2, as recommended for any potentially infectious human blood product, in the United States Center for Disease Control (USCDC) and National Institute of Health (USNIH) manual "Biosafety in Microbiological Laboratories", 1988. All bovine products and goat sera have been derived from animals of US origin and processed in USDA licensed facilities. 2.2 CHEMICAL HAZARD: The TMB Chromogenic Substrate containing TMB, is formulated with DMSO, an irritant and mucous membranes. In case of contact with any of these reagents, wash thoroughly with water. TMB is a suspected carcinogen. Stop Solution is an acidic and corrosive agent. Avoid contact with skin. 3. COMPOSITION OF THE KIT COMPONENTS 3.1 Microwell Strips, Microwell coated with TSH MAb, (96 wells) 3.2 Prolactin Reference Standard set, TSH Calibrators, 7 vials (1.0 ml) 3.3 TSH Enzyme Conjugate, 1 bottle (12 ml) 3.4 TMB Chromogenic Substrate, TMB Substrate, 1 bottle (12 ml) 3.5 Stop Solution, 2N HCl, 1 bottle (12 ml) 3.6 Wash Concentrate 50X, Detergent Concentrate, 1 bottle (15 ml) 3.7 Package Insert, paper, 1 piece.