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21 CFR 864.7400

§ 864.7400 Hemoglobin A

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

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21 CFR 864.7400, § 864.7400 Hemoglobin A, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89375
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(a) Identification. A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains). (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.