21 CFR 862.1177 — Radioimmunoassay, Cholyglycine, Bile Acids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1177
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KWW | Radioimmunoassay, Cholyglycine, Bile Acids | 2 | 6 | 3rd Party |
