Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine nitrite IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite in urine. FDA UDI
- Model / Reference
- U5.1-1S100 FDA UDI
- Description
- Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite in urine. FDA UDI
Identifiers
- Catalog Number
- U5.1-1S100 FDA UDI
- Primary DI / UDI-DI
- 00722066000373 FDA UDI
- 510(k) Number
- K061559 FDA UDI
- FDA Product Code
- JMT FDA UDIJIR FDA UDILJX FDA UDIJIO FDA UDIJIL 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 UDI862.1645 FDA UDI864.7675 FDA UDI864.6550 FDA UDI862.1340 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
No
FDA UDI
Convenience Kit
Yes
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 glucose IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinicalUrine blood IVD, kit, rapid colorimetric, clinicalUrine nitrite IVD, kit, rapid colorimetric, clinical
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 2f30f1a5-f822-4135-a2c8-173d65ec7da1 35 fields · synced Jun 1, 2026