Product Approval Information

Proper Name: Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction)
Tradename: COBAS AmpliScreen HIV-1 Test, version 1.5
Manufacturer: Roche Molecular Systems, Inc, License #1636

Package Insert (PDF - 548 KB) - Approved: May 23, 2007

Date: December 20, 2002
Indication: Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion
December 20, 2002 Approval Letter
Summary of Basis for Approval

Date: December 19, 2003
Indication: Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating)
December 19, 2003 Approval Letter
January 16, 2004 Corrected Letter

Date: March 9, 2005
Indication: Testing of individual cadaveric specimens (obtained from non-heart-beating donors)
March 9, 2005 Approval Letter

Date: May 23, 2007
Changes in labeling, testing requirement, and increase in reagent refrigerator cycles
May 23, 2007 Approval Letter