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MEMORANDUM

FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc) September 1991

Download the Final Memorandum
Final
Docket Number:
FDA-2013-S-0613
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is now regulating as licensed biologic products test kits that detect total (IgG and IgM) antibody to hepatitis B core antigen (anti-HBc). After 31 March 1991 anti-HBc kits shipped in interstate commerce and labeled for use in screening blood and blood products must bear a U.S. license number.

 

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