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CFR

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).

Code of Federal Regulations

[45 FR 60618, Sept. 12, 1980]
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