Identity
- Trade Name
- Dario 200 Test Strips Bundle FDA UDI
- Generic Name
- Glucose IVD, kit, enzyme spectrophotometry, rapid FDA UDI
- Device Name
- The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. FDA UDI
- Model / Reference
- 1213-05 FDA UDI
- Description
- The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850065006574 FDA UDI
- 510(k) Number
- K150817 FDA UDI
- FDA Product Code
- CGA FDA UDI
- GMDN Term
- Glucose IVD, kit, enzyme spectrophotometry, rapid 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
Yes
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
Yes
FDA UDI
Category: Glucose IVD, kit, enzyme spectrophotometry, rapid
Dario 200 Test Strips Bundle by Labstyle Innovation Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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
- 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 2bfa8f9f-534a-4d09-bbbb-8c638b6f13fd 34 fields · synced Jun 8, 2026