21 CFR 864.7400 — Hemoglobin A2 Quantitation

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7400

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).

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JPDHemoglobin A2 Quantitation2133rd Party
Innolitics

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