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Code · CFR · Title 21 — Food and Drugs · Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests · § 660.1

§ 660.1. Antibody to Hepatitis B Surface Antigen.

88 words·~1 min read·/us/cfr/t21/s§ 660.1·

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(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. [40 FR 29711, July 15, 1975]
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