To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent to detect the antigen in the appropriate sera of the reference panel by all test methods recommended by the manufacturer in the package insert.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.4 Potency test
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Amendment history
Federal Register documents that created or amended this section.
- 40 FR 29711 15 Jul 1975