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Electronic Code of Federal Regulations

e-CFR data is current as of November 15, 2019

Title 21Chapter ISubchapter HPart 864Subpart H → §864.7400


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


§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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