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e-CFR data is current as of November 25, 2020

Title 21Chapter ISubchapter HPart 864Subpart H → §864.7415


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


§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 (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]

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