21 C.F.R. § 864.7415   Abnormal hemoglobin assay.

Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart H—Hematology Kits and Packages

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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).

[45 FR 60618, Sept. 12, 1980]

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