Product Approval Information
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)