---
kind: "section"
citation: "21 C.F.R. § 864.7100"
title: "21"
number: "864.7100"
heading: "Red blood cell enzyme assay."
url: "https://uscodex.org/cfr/21/864.7100"
---

# §864.7100. Red blood cell enzyme assay.

- (a) **Identification.** Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60610, Sept. 12, 1980]

### Authority

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

### Amendments

[45 FR 60610, Sept. 12, 1980]