21 C.F.R. · Food and Drugs
21 C.F.R. § 864.7400

Hemoglobin A2 assay.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.7400 — Hemoglobin A2 assay.

§ 864.7400 Hemoglobin A 2 assay. (a) Identification. A hemoglobin A 2 assay is a device used to determine the hemoglobin A 2 content of human blood. The measurement of hemoglobin A 2 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). [45 FR 60617, Sept. 12, 1980]

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21 C.F.R. § 864.7400
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The regulatory text of 21 C.F.R. § 864.7400 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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