DART GAMMA-GT REAGENT SYSTEM
Device Facts
| Record ID | K834054 |
|---|---|
| Device Name | DART GAMMA-GT REAGENT SYSTEM |
| Applicant | Coulter Electronics, Inc. |
| Product Code | JQB · Clinical Chemistry |
| Decision Date | Feb 4, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
