Product Approval Information
Proper Name: Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
Tradename: None
Manufacturer: BioLife Plasma Services, L.P, License #1640
Date: January 31, 2007
Indication: Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR
January 31, 2007 Approval Letter
Summary Basis for Approval (PDF - 59 KB)