21 CFR 862.1070 — Saccharogenic, Amylase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1070
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CIJ | Saccharogenic, Amylase | 2 | 31 | 3rd Party |
| CIK | Radial Diffusion, Amylase | 2 | 0 | 3rd Party |
| CIW | Starch-Dye Bound Polymer, Amylase | 2 | 8 | 3rd Party |
| CJA | Amyloclastic, Amylase | 2 | 10 | 3rd Party |
| CJD | Nitrosalicylate Reduction, Amylase | 2 | 1 | 3rd Party |
| JFJ | Catalytic Methods, Amylase | 2 | 99 | 3rd Party |
| KHM | Nephelometric, Amylase | 2 | 6 | 3rd Party |
