Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine. FDA UDI
- Model / Reference
- U-KET-1S100 FDA UDI
- Description
- Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine. FDA UDI
Identifiers
- Catalog Number
- U-KET-1S100 FDA UDI
- Primary DI / UDI-DI
- 00722066000335 FDA UDI
- 510(k) Number
- K061559 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1435 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 ketone IVD, kit, rapid colorimetric, clinical
Rapid Response by BTNX Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine ketone IVD, kit, rapid colorimetric, clinical.
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- AIMSTRIP US-9 — GERMAINE LABORATORIES, INC. · Class I
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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 362b582c-d2be-4dfc-bc4e-9f229ca9d488 35 fields · synced May 29, 2026