§ 862.1187 Conjugated sulfolithocholic acid (SLCG) test system.
(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.