JQA · Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes
Clinical Chemistry · 21 CFR 862.1360 · Class 1
Overview
| Product Code | JQA |
|---|---|
| Device Name | Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes |
| Regulation | 21 CFR 862.1360 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
