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Code of Federal Regulations Title 21. Food and Drugs § 21.864.7415 Abnormal hemoglobin assay

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.864.7415 Abnormal hemoglobin assay - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-864-7415/

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