← Back to catalogue
Dimension Vista® C4 Complement Flex® reagent cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Dimension Vista® C4 Complement Flex® reagent cartridge FDA UDI
- Generic Name
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445891 FDA UDI
- Description
- For the quantitative measurement of C4 complement in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7028 FDA UDI
- Primary DI / UDI-DI
- 00842768006067 FDA UDI
- 510(k) Number
- K061852 FDA UDI
- FDA Product Code
- DBI FDA UDI
- GMDN Term
- Complement components C4/C4c IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5240 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: Complement components C4/C4c IVD, kit, nephelometry/turbidimetry
Dimension Vista® C4 Complement Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Complement components C4/C4c IVD, kit, nephelometry/turbidimetry.
- Atellica CH C4 — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
- Dimension® Flex® reagent cartridge C4 — Siemens Healthcare Diagnostics · Class II
- Tinaquant Complement C4 ver2 — Roche Diagnostics Corp. · Class II
- Tinaquant C4 — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA® Chemistry C4 Complement C4 Reagents — Siemens Healthcare Diagnostics · Class II
- Tinaquant Complement C4 ver2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
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 Products Ltd
Sources (1)
- FDA UDI 6ae81fbe-8fef-43b8-b844-4d8e4d254ef8 37 fields · synced May 29, 2026