Product Approval Information
Proper Name: Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
Tradename: UltraQual HCV-RT-PCR-Assay
Manufacturer: National Genetics Institute, License #1582
Date: September 18, 2001
Indication: Qualitative detection of hepatitis C virus (HCV) 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)