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.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.53 Controls for serological procedures
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 5579 11 Feb 1985
- 50 FR 16474 26 Apr 1985
- 51 FR 15611 25 Apr 1986
- 55 FR 11014 26 Mar 1990
- 67 FR 9587 4 Mar 2002
- 70 FR 14986 24 Mar 2005