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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Procleix HIV-1/HCV Assay

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
Indications:

  • 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.
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Supporting Documents

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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