21 CFR § 862.1187 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.

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

⚠ 2 pending changes to Part 862

(a) Identification. A conjugated sulfolithocholic acid (SLCG) test system is a device intended to measure the bile acid SLCG 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.

← § 862.1185 Compound S (11-deoxycortisol) test system.§ 862.1190 Copper test system. →