Ammonia test system.

21 C.F.R. § 862.1065
in effectEffective: 2024-07-01
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(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.

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