21 CFR § 862.1065 - Ammonia test system.

---
identifier: "/us/cfr/t21/s862.1065"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1065 - Ammonia test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1065"
section_name: "Ammonia test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.