21 CFR § 862.1315 - Galactose-1-phosphate uridyl transferase test system.

---
identifier: "/us/cfr/t21/s862.1315"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1315 - Galactose-1-phosphate uridyl transferase test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1315"
section_name: "Galactose-1-phosphate uridyl transferase test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.