§ 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
Current through Sep 8, 2026 · Read all of Part 660
The 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.
[50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005]