To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the antibody 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
§ 660.43 Potency test
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