21 CFR § 864.7400 Hematology and Pathology Devices

§ 864.7400 Hemoglobin A2 assay.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.7375 Glutathione reductase assay.§ 864.7415 Abnormal hemoglobin assay. →