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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L

Proper Name: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests
                     COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
Tradename: None
Manufacturer: Roche Molecular Systems, Inc
Indication:

  • Quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acid in human plasma for use in conjunction with clinical presentation and other laboratory markers
 

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

Division of Communication and Consumer Affairs

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Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002