NGJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1510
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IND URINARY TRACT INFECTION (UTI) TEST STRIPS (K103037) | Ind Diagnostic, Inc. | 2012-04-17 |
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