21 C.F.R. § 660.40 Hepatitis B Surface Antigen.
Title 21 - Food and Drugs
(a) Proper name and definition. The proper name of this product shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen. (b) Source. The source of the product shall be blood, plasma, serum, or tissue, obtained aseptically from nonhuman primates that have met the applicable requirements of §600.11 of this chapter, or from human donors whose blood is positive for the Hepatitis B Surface Antigen.
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart E—Hepatitis B Surface Antigen
§ 660.40 Hepatitis B Surface Antigen.
