Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests
Current through Sep 8, 2026
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.
Cross References:
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.
Sections
- § 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.
- § 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.
- § 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.
- § 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.
- § 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.