TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS
Subpart A - Antibody to Hepatitis B Surface Antigen
§ 660.1 - Antibody to Hepatitis B Surface Antigen.
§ 660.2 - General requirements.
§ 660.3 - Reference panel.
§ 660.4 - Potency test.
§ 660.5 - Specificity.
§ 660.6 - Samples; protocols; official release.
Subpart B [Reserved]
Subpart C - Blood Grouping Reagent
§ 660.20 - Blood Grouping Reagent.
§ 660.21 - Processing.
§ 660.22 - Potency requirements with reference preparations.
§ 660.25 - Potency tests without reference preparations.
§ 660.26 - Specificity tests and avidity tests.
§ 660.28 - Labeling.
Subpart D - Reagent Red Blood Cells
§ 660.30 - Reagent Red Blood Cells.
§ 660.31 - Eligibility of donor.
§ 660.32 - Collection of source material.
§ 660.33 - Testing of source material.
§ 660.34 - Processing.
§ 660.35 - Labeling.
§ 660.36 - Samples and protocols.
Subpart E - Hepatitis B Surface Antigen
§ 660.40 - Hepatitis B Surface Antigen.
§ 660.41 - Processing.
§ 660.43 - Potency test.
§ 660.44 - Specificity.
§ 660.45 - Labeling.
§ 660.46 - Samples; protocols; official release.
Subpart F - Anti-Human Globulin
§ 660.50 - Anti-Human Globulin.
§ 660.51 - Processing.
§ 660.52 - Reference preparations.
§ 660.53 - Controls for serological procedures.
§ 660.54 - Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
§ 660.55 - Labeling.
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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.
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