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
June 4, 2004 Approval Letter - Procleix HIV-1/HCV Assay
Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testingFebruary 27, 2002 Approval Letter - Procleix HIV-1/HCV Assay
Assay 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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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
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