---
kind: "section"
citation: "21 C.F.R. § 864.7360"
title: "21"
number: "864.7360"
heading: "Erythrocytic glucose-6-phosphate dehydrogenase assay."
url: "https://uscodex.org/cfr/21/864.7360"
---

# §864.7360. Erythrocytic glucose-6-phosphate dehydrogenase assay.

- (a) **Identification.** An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.
- (b) **Classification.** Class II (performance standards).

## Notes

### Amendments

[45 FR 60616, Sept. 12, 1980]

### Authority

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

### Amendments

[45 FR 60616, Sept. 12, 1980]