CIK · Radial Diffusion, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | CIK |
|---|---|
| Device Name | Radial Diffusion, Amylase |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
