TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
Device Facts
| Record ID | K852611 |
|---|---|
| Device Name | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE |
| Applicant | Miles Laboratories, Inc. |
| Product Code | CDM · Clinical Chemistry |
| Decision Date | Sep 3, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1785 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.
