Note: Ingredients listed on restricted chemical lists
General Information
Product name
NeuMoDx HCV Calibrator Kit
CAS No.
26628-22-8
Manufacturer Name
NeuMoDx Molecular Inc
Emergency telephone
24-HR Emergency Exposure
Icons in SDS
Company Information
company name
NeuMoDx Molecular Inc
e-mail address of the competent person responsible for the Safety Data Sheet
info@neumodx.com
GHS Information
Signal word
Warning
Section 2
SECTION 2: Hazards identification
OSHA Hazards EU/EEC This substance is not hazardous as defined by OSHA 29CFR 1910.1200 but this product does contain live Hepatitis C 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 HCV External Calibrator Kit is the final finished product for use on the NeuMoDx Molecular System. The NeuMoDx HCV External Calibrator Kit
Contains
Hepatitis C Virus (HCV) in Basematrix (Seracare Life Sciences Inc) stored in six tubes per kit at two concentrations of HCV (three tubes per concentration). The final solution is yellow-tan liquid. This product contains material derived from human plasma mixed with a potentially infectious agent and should be treated/handled as a potential biohazard. Vendors responsible for the materials going into the NeuMoDx HCV External Calibrator Kit have stated that the human source material 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. Product contains sodium azide as a preservation at a concentration below threshold amount for reporting according to OSHA hazard communication regulations (1%) but at a concentration that should be considered for disposal and other environmental considerations.
2.2 Label elements
Not required. GHS single word: Warning. Hazard pictograms/statements: Not required.
Precautionary statements
Not required.
