Code of Federal Regulations · Section

§ 862.1177 — Cholylglycine Test System

21 C.F.R. § 862.1177

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(a) Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

(b) Classification. Class II.

21 C.F.R. § 862.1175 21 C.F.R. § 862.1180

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