Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine. FDA UDI
- Model / Reference
- UTI-1S1 FDA UDI
- Description
- Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine. FDA UDI
Identifiers
- Catalog Number
- UTI-1S1 FDA UDI
- Primary DI / UDI-DI
- 00722066003404 FDA UDI
- 510(k) Number
- K063295 FDA UDI
- FDA Product Code
- JMT FDA UDILJX FDA UDI
- GMDN Term
- Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1510 FDA UDI864.7675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine nitrite IVD, kit, rapid colorimetric, clinicalUrine leukocyte IVD, kit, rapid colorimetric, clinicalMultiple urine analyte IVD, kit, rapid colorimetric, self-testing
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple urine analyte IVD, kit, rapid colorimetric, self-testing.
- LYZ — Changchun Lyz Technology Co., Ltd. · Class I
- Starling Medical, Inc — STARLING MEDICAL · Class I
- Vivoo At-Home Urinary Tract Infection Test — VIVOSENS INC · Class I
- Starling Medical, Inc — STARLING MEDICAL · Class I
- Starling Medical, Inc — STARLING MEDICAL · Class I
Cleared under the same submission
K063295 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI e9573913-9fb2-4f5e-92d3-9d948c5e9f4e 35 fields · synced May 31, 2026