21 CFR § 862.1177 - Cholylglycine test system.

---
identifier: "/us/cfr/t21/s862.1177"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1177 - Cholylglycine test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1177"
section_name: "Cholylglycine test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.