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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests |
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Subpart A - Antibody to Hepatitis B Surface Antigen |
§ 660.1 - Antibody to Hepatitis B Surface Antigen.
Latest version.
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§ 660.1 Antibody to Hepatitis B Surface Antigen.
(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]