Vaccines, Blood & Biologics
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UltraQual HCV RT-PCR Assay
Proper Name: Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay
Tradename: UltraQual HCV RT-PCR Assay
Manufacturer: National Genetics Institute
Indication:
- 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
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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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