21 CFR 862.1065
§ 862.1065 Ammonia test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1065, § 862.1065 Ammonia test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89046
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.