Identity
- Trade Name
- Dario Blood Glucose Monitoring System FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. FDA UDI
- Model / Reference
- 1015-05 FDA UDI
- Description
- The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850065006161 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dario Blood Glucose Monitoring System by Labstyle Innovation Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150817 also covers:
- 100 Blood Glucose Test Strip — LABSTYLE INNOVATION LTD
- 25 Blood Glucose Test Strip — LABSTYLE INNOVATION LTD
- 50 Dario Blood Glucose Test Strip — LABSTYLE INNOVATION LTD
- Dario 200 Test Strips Bundle — LABSTYLE INNOVATION LTD
- Dario 300 Test Strips Bundle — LABSTYLE INNOVATION LTD
- Dario Blood Glucose Monitoring System — LABSTYLE INNOVATION LTD
- Dario Glucose Control Solution — LABSTYLE INNOVATION LTD
- Dario LC Blood Glucose Monitoring System & Dario Membership — LABSTYLE INNOVATION LTD
- Dario LC Starter Kit — LABSTYLE INNOVATION LTD
- Dario Super Saver MIB-Supplies — LABSTYLE INNOVATION LTD
- Dario USB-C Blood Glucose Monitoring System & Dario Membership — LABSTYLE INNOVATION LTD
- Dario® USB-C Blood Glucose Monitoring System - Starter Kit — LABSTYLE INNOVATION LTD
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
- Labstyle Innovation Ltd
Sources (1)
- FDA UDI 85648e34-a1e9-4c98-8d98-e8f78aa93d0c 35 fields · synced May 31, 2026