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LucidPlus B-Ketone Plus Blood Glucose Monitoring System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- LucidPlus B-Ketone Plus Blood Glucose Monitoring System FDA UDI
- Generic Name
- Multiple clinical chemistry analyte monitoring system IVD, point-of-care FDA UDI
- Model / Reference
- 300300 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851225008001 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Multiple clinical chemistry analyte monitoring system IVD, point-of-care 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple clinical chemistry analyte monitoring system IVD, point-of-care
LucidPlus B-Ketone Plus Blood Glucose Monitoring System by Vidan Diagnostics, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Vidan Diagnostics, Llc
Sources (1)
- FDA UDI 831cff4b-e8f7-4f74-b534-d851ae81387c 32 fields · synced May 30, 2026