Identity
- Trade Name
- bkt ß-Ketone & blood glucose monitoring system FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
- Device Name
- Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS FDA UDI
- Model / Reference
- TD-4279 FDA UDI
- Description
- Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858538007127 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyte monitoring system IVD, home-use
bkt ß-Ketone & blood glucose monitoring system by Adam Lawrence — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.
- FORA — FORA CARE INC. · Class II
- FORA — FORA CARE INC. · Class II
- STAT-Site WB Blood Glucose Test Strips — STANBIO LABORATORY, L.P. · Class II
- KetoSens — i-SENS, Inc. · Class I
- KetoSens — i-SENS, Inc. · Class I
- STAT-Site WB Blood Glucose Test Strips — STANBIO LABORATORY, L.P. · Class II
- FreeStyle Lite — ABBOTT DIABETES CARE INC · Class II
- Blood Ketone Control solution(level 3) — e-Linkcare Meditech Co., Ltd · Class I
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
- Adam Lawrence
Sources (1)
- FDA UDI ffe702a2-6c3d-4ad1-bfdb-7bdcdf7a1a48 33 fields · synced Jun 1, 2026