21 CFR 862.1177 - Cholylglycine test system.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart B [§ 862.1020 - § 862.1840]

§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371

source: 52 FR 16122, May 1, 1987, unless otherwise noted.

cite as: 21 CFR 862.1177