862.1177 Cholylglycine test system.§ 862.1177 Cholylglycine test system.
(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.