21 CFR 660.53

§ 660.53 Controls for serological procedures.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 660.53, § 660.53 Controls for serological procedures, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88570
Permanent ID: ys:prov:88570@1
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.