---
kind: "section"
citation: "21 C.F.R. § 862.1070"
title: "21"
number: "862.1070"
heading: "Amylase test system."
url: "https://uscodex.org/cfr/21/862.1070"
---

# §862.1070. Amylase test system.

- (a) **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).
- (b) **Classification.** Class II.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.