Product Approval Information
Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay
Tradename: COBAS TaqScreen MPX Test
Manufacturer: Roche Molecular Systems, Inc, License No. 1636
Date: December 30, 2008
Indication: For the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma.
12/30/2008 Approval Letter
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue