Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 864 - Hematology and Pathology Devices |
Subpart H - Hematology Kits and Packages |
§ 864.7415 - Abnormal hemoglobin assay.
Latest version.
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§ 864.7415 Abnormal hemoglobin assay.
(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 (performance standards). 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.
[45 FR 60618, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]