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Code · CFR · Title 21 — Food and Drugs · Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests · § 660.40

§ 660.40. Hepatitis B Surface Antigen.

83 words·~1 min read·/us/cfr/t21/s§ 660.40·

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(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.
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