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Part 660
FEDERAL · 21 CFR
Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests
31 sections · Title 21: Food and Drugs
§ 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.