Vaccines, Blood & Biologics
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COBAS AmpliScreen HIV-1 Test
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
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
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Supporting Documents
May 23, 2007 Approval Letter - COBAS AmpliScreen HIV-1 Test
Indication:Changes in labeling, testing requirement, and increase in reagent refrigerator cyclesMarch 9, 2005 Approval Letter - COBAS AmpliScreen HIV-1 Test
Indication: Testing of individual cadaveric specimens (obtained from non-heart-beating donors)January 16, 2004 Corrected Letter - COBAS AmpliScreen HIV-1 Test December 19, 2003 Approval Letter - COBAS AmpliScreen HIV-1 Test
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 donorsDecember 20, 2002 Approval Letter - COBAS AmpliScreen HIV-1 Test Summary Basis for Approval - COBAS Ampliscreen HIV-1 Test
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