21 CFR § 660.53 Additional Standards for Diagnostic Substances for Laboratory Tests

§ 660.53 Controls for serological procedures.

Current through Sep 8, 2026 · Read all of Part 660

Red blood cells sensitized with complement shall be tested with appropriate positive and negative control antisera. All tests shall be performed in accordance with serological testing procedures approved by the Director, Center for Biologics Evaluation and Research.

[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]

← § 660.52 Reference preparations.§ 660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. →