Product Approval Information
Proper Name: Human Immunodeficiency Virus Type 1 and / or Hepatitis C Virus (HIV-1 and Hepatitis C Virus / Nucleic Acid Pooled Testing / Synthetic)
Tradename: Procleix HIV-1/HCV Assay
Manufacturer: Gen-Probe, Inc, License #1592
Package Insert (PDF - 1.38 MB) - May, 2007
Date: February 27, 2002
Indication: Assay for the qualitative detection of human immunodeficiency virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion
February 27, 2002 Approval Letter
Talkpaper - FDA Approves First Nucleic Acid Test (NAT) System to Screen Whole Blood Donors for Infections with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) - 2/28/2002
Date: June 4, 2004
Expanded Indication for Use: Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing; and testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors)
June 4, 2004 Approval Letter