21 CFR
Part 660 Additional Standards for Diagnostic Substances for Laboratory Tests
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 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 1 × 483
- § 660.32 Collection of source material 3 × 483
- § 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