§660.54. Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
21 C.F.R. § 660.54
The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research:
Potency tests for determining anti-IgG and anti-complement activity.
Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
Notes, amendments, and revision history
Amendments
[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]
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.
Amendments
[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]