---
kind: "section"
citation: "21 C.F.R. § 862.1065"
title: "21"
number: "862.1065"
heading: "Ammonia test system."
url: "https://uscodex.org/cfr/21/862.1065"
---

# §862.1065. Ammonia test system.

- (a) **Identification.** An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
- (b) **Classification.** Class I.

## 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.