Product Approval Information

Proper Name: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
Tradename: UltraQual HIV-1 RT-PCR Assay
Manufacturer: National Genetics Institute, License #1582


Date: September 18, 2001
Indication: Qualitative detection of human immunodeficiency virus type 1(HIV-1) of ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples
September 18, 2001 Approval Letter
    September 18, 2001 Companion Approval Letter for Source Plasma
Summary of Basis for Approval (PDF - 45 KB)

 
Updated: May 13, 2005