Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge UCFP FDA UDI
- Generic Name
- Total protein IVD, kit, spectrophotometry FDA UDI
- Device Name
- Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 180 Tests FDA UDI
- Model / Reference
- 10445168 FDA UDI
- Description
- Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 180 Tests FDA UDI
Identifiers
- Catalog Number
- K3026 FDA UDI
- Primary DI / UDI-DI
- 00842768015502 FDA UDI
- FDA Product Code
- CEK FDA UDI
- GMDN Term
- Total protein IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1635 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total protein IVD, kit, spectrophotometry
Dimension Vista® Flex® reagent cartridge UCFP by Siemens Healthcare Diagnostics — 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5767e186-8b2d-4d9b-8826-a1da0a365070 36 fields · synced May 30, 2026