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

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages

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§ 864.7400   Hemoglobin A₂ assay.

(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).

[45 FR 60617, Sept. 12, 1980]

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