---
kind: "section"
citation: "21 C.F.R. § 862.1315"
title: "21"
number: "862.1315"
heading: "Galactose-1-phosphate uridyl transferase test system."
url: "https://uscodex.org/cfr/21/862.1315"
---

# §862.1315. Galactose-1-phosphate uridyl transferase test system.

- (a) **Identification.** A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
- (b) **Classification.** Class II.

## Notes

### Authority

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

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.