CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART H—Hematology Kits and Packages (§864.7040 to §864.7925) > 864.7415—Abnormal hemoglobin assay.

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]