Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine pH IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine. FDA UDI
- Model / Reference
- U5.3-1S100 FDA UDI
- Description
- Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine. FDA UDI
Identifiers
- Catalog Number
- U5.3-1S100 FDA UDI
- Primary DI / UDI-DI
- 00722066004364 FDA UDI
- 510(k) Number
- K061559 FDA UDI
- FDA Product Code
- JIO FDA UDIJIR FDA UDIJIN FDA UDIJIL FDA UDICEN FDA UDI
- GMDN Term
- Urine pH IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 FDA UDI862.1645 FDA UDI862.1435 FDA UDI862.1340 FDA UDI862.1550 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 ketone IVD, kit, rapid colorimetric, clinicalUrine protein IVD, kit, rapid colorimetric, clinicalUrine blood IVD, kit, rapid colorimetric, clinical
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urine pH IVD, kit, rapid colorimetric, clinical.
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- Mission Urinalysis Reagent Strips — ACON Laboratories, Inc. · Class I
- AIMSTRIP US-4 — GERMAINE LABORATORIES, INC. · Class II
- AIMSTRIP US-11 — GERMAINE LABORATORIES, INC. · Class I
- One+Step pH — DFI CO., LTD · Class I
- Multi Use 9 drug (CASE) — Quest Diagnostics
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 II | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI a064c57e-8046-4ac4-ab64-8e919c3eec46 35 fields · synced May 30, 2026