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Product Approval Information - Licensing Action

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Proper name: HIV-1 / HCV Assay
Tradename: Procleix
Manufacturer: Gen-Probe, Inc, San Diego, CA, License #1592
Indication for Use: 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
Approval Date: 2/27/2002
Type of submission: Biologics license application

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Approval Letter - (Text)

Talkpaper - FDA Approves First Nucleic Acid Test (NAT) System to Screen Whole Blood Donors for Infections with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

 

Updated March 4, 2002
 
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