21 CFR § 862.1177 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1177 Cholylglycine test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1175 Cholesterol (total) test system.§ 862.1180 Chymotrypsin test system. →