Vaccines, Blood & Biologics
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ABBOTT PRISM HBcore
Proper Name: Hepatitis B Virus Core Antigen (E.coli, Recombinant)
Tradename: ABBOTT PRISM HBcore
Manufacturer: Abbott Laboratories, License #0043
Labels -
ABBOTT PRISM HBcore (PDF - 213 KB) - October, 2005
ABBOTT PRISM Run Control Kit (PDF - 136 KB) - October, 2005
ABBOTT PRISM Positive Run Control Kit (PDF - 136 KB) - October, 2005
Date: October 13, 2005
Indication: Qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma; screening test for blood and plasma to prevent transmission of hepatitis B virus (HBV) to recipients of blood and blood components
October 13, 2005 Approval Letter
Summary Basis for Approval (PDF - 108 KB)
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

