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Vaccines, Blood & Biologics
ABBOTT PRISM HCV
Proper Name: Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)
Tradename: ABBOTT PRISM HCV
Manufacturer: Abbott Laboratories, License #0043
Package Insert (PDF - 357 KB) - July, 2007
Date: July 11, 2007
Indication: For the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens
July 11, 2007 Approval Letter
Summary of Basis for Approval (PDF - 113 KB)
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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