COBAS REAGENT FOR A-AMYLASE
Device Facts
| Record ID | K801295 |
|---|---|
| Device Name | COBAS REAGENT FOR A-AMYLASE |
| Applicant | Roche Analytical Instruments, Inc. |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Jul 8, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
