---
kind: "section"
citation: "21 C.F.R. § 864.7440"
title: "21"
number: "864.7440"
heading: "Electrophoretic hemoglobin analysis system."
url: "https://uscodex.org/cfr/21/864.7440"
---

# §864.7440. Electrophoretic hemoglobin analysis system.

- (a) **Identification.** An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60620, Sept. 12, 1980]

### Authority

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

### Amendments

[45 FR 60620, Sept. 12, 1980]