Title 21, Part 660 — Additional Standards for Diagnostic Substances for Laboratory Tests
31 sections
Section 660.1
Antibody to Hepatitis B Surface Antigen.
Section 660.2
General requirements.
Section 660.3
Reference panel.
Section 660.4
Potency test.
Section 660.5
Specificity.
Section 660.6
Samples; protocols; official release.
Section 660.20
Blood Grouping Reagent.
Section 660.21
Processing.
Section 660.22
Potency requirements with reference preparations.
Section 660.25
Potency tests without reference preparations.
Section 660.26
Specificity tests and avidity tests.
Section 660.28
Labeling.
Section 660.30
Reagent Red Blood Cells.
Section 660.31
Eligibility of donor.
Section 660.32
Collection of source material.
Section 660.33
Testing of source material.
Section 660.34
Processing.
Section 660.35
Labeling.
Section 660.36
Samples and protocols.
Section 660.40
Hepatitis B Surface Antigen.
Section 660.41
Processing.
Section 660.43
Potency test.
Section 660.44
Specificity.
Section 660.45
Labeling.
Section 660.46
Samples; protocols; official release.
Section 660.50
Anti-Human Globulin.
Section 660.51
Processing.
Section 660.52
Reference preparations.
Section 660.53
Controls for serological procedures.
Section 660.54
Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
Section 660.55
Labeling.