JIB · U.V. Method, Galactose
Clinical Chemistry · 21 CFR 862.1310 · Class 1
Overview
| Product Code | JIB |
|---|---|
| Device Name | U.V. Method, Galactose |
| Regulation | 21 CFR 862.1310 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.
Classification Rationale
Class I.
Cleared Devices (0)
No cleared devices on record.
