JLJ · Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
Clinical Chemistry · 21 CFR 862.1315 · Class 2
Overview
| Product Code | JLJ |
|---|---|
| Device Name | Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate |
| Regulation | 21 CFR 862.1315 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K860501 | FLAME PHOTOMETER STANDARD | Medical Specialties, Inc. | Apr 7, 1986 | SESE |
Top Applicants
- Medical Specialties, Inc. — 1 clearance
