Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
21 C.F.R. § 660.54
in effectEffective: 2024-07-01The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research:
(a) Potency tests for determining anti-IgG and anti-complement activity.
(b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026