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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) Proper name and definition. The proper name of this product shall be Antibody to Hepatitis B Surface Antigen. The product is defined as a preparation of serum containing antibody to hepatitis B surface antigen.
(b) Source. The source of this product shall be plasma or blood, obtained aseptically from animals immunized with hepatitis B surface antigen, which have met the applicable requirements of § 600.11 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.660.1 Antibody to Hepatitis B Surface Antigen - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-660-1/
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