21 CFR 864.7415
§ 864.7415 Abnormal hemoglobin assay.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.7415, § 864.7415 Abnormal hemoglobin assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89376
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Full text
(a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.
(b) Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.