BIOTEL (TM)/UTI
Device Facts
| Record ID | K855238 |
|---|---|
| Device Name | BIOTEL (TM)/UTI |
| Applicant | American Diagnostic Corp. |
| Product Code | JMT · Clinical Chemistry |
| Decision Date | May 9, 1986 |
| 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.
