NGJ · Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Clinical Chemistry · 21 CFR 862.1510 · Class 1
Overview
| Product Code | NGJ |
|---|---|
| Device Name | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter |
| Regulation | 21 CFR 862.1510 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | Ind Diagnostic, Inc. | Apr 17, 2012 | SESE |
Top Applicants
- Ind Diagnostic, Inc. — 1 clearance
