NeuMoDx HBV External Controls

SECTION 2: Hazards identification

29 CFR 1910.1200) EU/EEC This substance is not hazardous as defined by OSHA 29CFR 1910.1200 but this product does contain live Hepatitis B Virus and should be handled according to good lab practices, with proper personal protective equipment, proper engineering controls and within the parameters of the purchaser’s safety program.

2.1 Classification of the substance or mixture

The product has not been fully tested as hazardous according to the Globally Harmonized System (GHS). CLP The NeuMoDx HBV External Controls are the final finished products for use on the NeuMoDx Molecular System. The NeuMoDx HBV External Controls are provided in a kit containing 30 tubes of Basematrix - 15 tubes with HBV virus added (positive control) and 15 tubes without (negative control). The final solution is yellow-tan liquid. This product contains material derived from human plasma and, in the case of the positive controls, mixed with a potentially infectious agent and should be treated/handled as a potential biohazard. Vendors responsible for the materials going into the NeuMoDx HBV External Controls have stated that the human source material has been tested and shown by FDA approved methods to be free from antibodies to Human Immune Deficiency Virus and Hepatitis C and is non- reactive for HBsAg and anti-HIV-1/2, anti-HCV, anti-HTLV I/II, anti-HBs, and anti- HBc. Exemptions for disclosing some component information are pursuant to CLP Article 1(5)(d) and 29 CFR 1910. 1200(g)(2)(i)(C)(1)&(2). Please refer to package insert for additional information, and handle product as potentially biohazardous.

2.2 Label elements

Not required.

Signal word

Warning. Hazard Pictograms/statements: Not required.

Precautionary statements

Not required.

2.3 Other hazards

Biohazard. Handle as if capable of transmitting infectious agents.