BILE ACIDS REAGENT
Device Facts
| Record ID | K872296 |
|---|---|
| Device Name | BILE ACIDS REAGENT |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | KWW · Clinical Chemistry |
| Decision Date | Aug 26, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1177 |
| Device Class | Class 2 |
Regulatory Classification
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.
