Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge BUN FDA UDI
- Generic Name
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Urea Nitrogen Flex® reagent cartridge, 1680 Tests FDA UDI
- Model / Reference
- 10445159 FDA UDI
- Description
- Urea Nitrogen Flex® reagent cartridge, 1680 Tests FDA UDI
Identifiers
- Catalog Number
- K1021 FDA UDI
- Primary DI / UDI-DI
- 00842768015601 FDA UDI
- 510(k) Number
- K051087 FDA UDI
- FDA Product Code
- CDQ FDA UDI
- GMDN Term
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1770 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urea IVD, kit, enzyme spectrophotometry
Dimension Vista® Flex® reagent cartridge BUN by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, kit, enzyme spectrophotometry.
- Pointe Scientific, Inc. BUN — POINTE SCIENTIFIC, INC. · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- Urea Nitrogen (BUN) Test — STANBIO LABORATORY, L.P. · Class II
- Pointe BUN Reagent — POINTE SCIENTIFIC, INC. · Class II
- UREA UV SL — VITALSCIENTIFIC
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
- Yumizen C1200 Uric acid — Horiba Abx · Class I
- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K051087 also covers:
- Dimension Vista Barcode Labels — Siemens Healthcare Diagnostics
- Dimension Vista® 1500 Intelligent Lab System — Siemens Healthcare Diagnostics
- Dimension Vista® 500 — Siemens Healthcare Diagnostics
- Dimension Vista® 500 Intelligent Lab System — Siemens Healthcare Diagnostics
- Dimension Vista® Aliquot Plates — Siemens Healthcare Diagnostics
- Dimension Vista® Cuvette Wash Solution 5 — Siemens Healthcare Diagnostics
- Dimension Vista® Cuvettes — Siemens Healthcare Diagnostics
- Dimension Vista® Empty Vials Kit — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge CHK — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge EMPTY — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge PHNO — Siemens Healthcare Diagnostics
- Dimension Vista® LOCI® Reaction Vessels — Siemens Healthcare Diagnostics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 2398d96d-e078-41d1-bc19-d1f973638605 37 fields · synced May 29, 2026