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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448