21 CFR § 864.7415 - Abnormal hemoglobin assay.

---
identifier: "/us/cfr/t21/s864.7415"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7415 - Abnormal hemoglobin assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7415"
section_name: "Abnormal hemoglobin assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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]