21 CFR 862.1315 — Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1315
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JLJ | Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate | 2 | 1 | 3rd Party |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 2 | 7 | 3rd Party |
