21 C.F.R. § 862.1065

Current through September 30, 2024
Section 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.

21 C.F.R. § 862.1065