---
kind: "section"
citation: "21 C.F.R. § 864.7470"
title: "21"
number: "864.7470"
heading: "Glycosylated hemoglobin assay."
url: "https://uscodex.org/cfr/21/864.7470"
---

# §864.7470. Glycosylated hemoglobin assay.

- (a) **Identification.** A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60621, Sept. 12, 1980]

### Authority

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

### Amendments

[45 FR 60621, Sept. 12, 1980]