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Product Approval Information - Licensing Action

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Proper name: Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
Tradename: UltraQual HCV-RT-PCR-Assay
Manufacturer: National Genetics Institute, Los Angeles, CA, License #1582
Indication for Use: Qualitative detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples
Approval Date: 9/18/2001
Type of submission: Biologics license application

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Approval Letter - (Text)
    Companion Approval Letter for Source Plasma - (Text)

 

Updated October 2, 2001
 
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