---
kind: "section"
citation: "21 C.F.R. § 864.7415"
title: "21"
number: "864.7415"
heading: "Abnormal hemoglobin assay."
url: "https://uscodex.org/cfr/21/864.7415"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60618, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60618, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]