eCFR Reference Browser

---

title: "21 CFR §864.7400"

source: "https://www.ecfr.gov/current/title-21/section-864.7400"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "864"

part_subject: "HEMATOLOGY AND PATHOLOGY DEVICES"

subpart_code: "H"

subpart_subject: "Hematology Kits and Packages"

section_number: "864.7400"

section_subject: "Hemoglobin A 2 assay."

cfr_reference: "21 CFR 864.7400"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§864.7400 - Hemoglobin A 2 assay.