21 CFR 660.53 - Controls for serological procedures.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart F [§ 660.50 - § 660.55]

§ 660.53 - Controls for serological procedures.

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]

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

cite as: 21 CFR 660.53