Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
The Test, Nitrite, Urinary, Non-Quantitative, Over The Counter (product code NGJ) is an in vitro diagnostic test for consumer use that detects nitrites in urine as a qualitative indicator of bacterial urinary tract infection, since nitrite-producing bacteria convert dietary nitrates to nitrites. It is classified as an FDA Class 1 device within the Clinical Chemistry specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NGJ
- Device Class
- FDA class 1
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | Apr 17, 2012 | Substantially Equivalent | Ind Diagnostic, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.