Vaccines, Blood & Biologics

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

Supporting Documents

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 08/13/2010
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.