StacksVerified U.S. regulatory reference

21 CFR §862.1177

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II.