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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)

    
 

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  • (800) 835-4709
  • (301) 827-1800
  • Consumer Affairs Branch (CBER)

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    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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