21 CFR 864.7440
§ 864.7440 Electrophoretic hemoglobin analysis system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7440, § 864.7440 Electrophoretic hemoglobin analysis system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89378
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Full text
(a) Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.