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OneTouch Ultra Blue Test Strips
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K923544
Identity
- Trade Name
- OneTouch Ultra Blue Test Strips FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters FDA UDI
- Model / Reference
- 024-273 FDA UDI
- Description
- OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters FDA UDI
Identifiers
- Catalog Number
- 024-273 FDA UDI
- Primary DI / UDI-DI
- 00353885012652 FDA UDI
- FDA Product Code
- NBW FDA UDICGA FDA UDI
- GMDN Term
- Glucose IVD, kit, electrometry 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
Yes
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: Glucose IVD, kit, electrometry
OneTouch Ultra Blue Test Strips by Lifescan, Inc. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923544 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifescan, Inc.
Sources (2)
- FDA UDI c8e30e04-8c2a-4ddc-9b99-bcfb6757bcb0 59 fields · synced Jun 18, 2026
- FDA 510(k) K923544 1 fields · synced May 25, 2026