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Vaccines, Blood & Biologics
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) Assay
Proper Name: Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay
Tradename: None
Manufacturer: BioLife Plasma Services, L.P, License #1640
Date: February 9, 2007
Indication: Detection of Hepatitis C Virus RNA in Human Source Plasma samples by PCR
February 9, 2007 Approval Letter
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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