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21 C.F.R. § 660.1   Antibody to Hepatitis B Surface Antigen.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart A—Antibody to Hepatitis B Surface Antigen

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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]

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