BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS
Device Facts
| Record ID | K875248 |
|---|---|
| Device Name | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS |
| Applicant | Bioscan Instruments, Inc. |
| Product Code | JMT · Clinical Chemistry |
| Decision Date | Feb 24, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1510 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.
