Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine creatinine IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative determination of Albumin and Creatinine in urine. FDA UDI
- Model / Reference
- U2.3-1S25 FDA UDI
- Description
- Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative determination of Albumin and Creatinine in urine. FDA UDI
Identifiers
- Catalog Number
- U2.3-1S25 FDA UDI
- Primary DI / UDI-DI
- 00722066003640 FDA UDI
- 510(k) Number
- K061419 FDA UDI
- FDA Product Code
- JIR FDA UDIJFY FDA UDI
- GMDN Term
- Urine creatinine IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1645 FDA UDI862.1225 FDA UDI
- Commercial Distribution
- Not 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
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K061419 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 1172a376-bdb5-4200-853c-bda5419bf5b3 36 fields · synced May 30, 2026