Issue Date: September 10, 1991
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final
FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)
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.
Download the Guidance Document
