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21 CFR 864.7825

§ 864.7825 Sickle cell test.

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

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21 CFR 864.7825, § 864.7825 Sickle cell test, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89390
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(a) Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases. (b) Classification. Class II (performance standards).

Legislative history

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