URINE REAGENT STRIPS-8 PARAMETERS
Device Facts
| Record ID | K943436 |
|---|---|
| Device Name | URINE REAGENT STRIPS-8 PARAMETERS |
| Applicant | Teco Diagnostics |
| Product Code | JJB · Clinical Chemistry |
| Decision Date | Apr 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1115 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.
