TOTAL GALACTOSE
Device Facts
| Record ID | K894011 |
|---|---|
| Device Name | TOTAL GALACTOSE |
| Applicant | Alpkem Corp. |
| Product Code | KQP · Clinical Chemistry |
| Decision Date | Jan 11, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1315 |
| Device Class | Class 2 |
Regulatory Classification
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.
