INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
Device Facts
| Record ID | K001569 |
|---|---|
| Device Name | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | JFJ · Clinical Chemistry |
| Decision Date | Jun 26, 2000 |
| 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).
