Identity
- Trade Name
- KetoSens FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) FDA UDI
- Model / Reference
- 276265 FDA UDI
- Description
- KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885325001495 FDA UDI
- 510(k) Number
- K201551 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Multiple clinical chemistry analyte monitoring system IVD, home-use
KetoSens by i-SENS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- i-SENS, Inc.
Sources (1)
- FDA UDI 3293d564-5a0b-466c-84e5-726b8c94546d 36 fields · synced May 30, 2026