21 CFR Part 660
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
- PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
- 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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