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DImension Vista® Cystatin C Flex® reagent cartridge
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DImension Vista® Cystatin C Flex® reagent cartridge FDA UDI
- Generic Name
- Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445895 FDA UDI
- Description
- For the quantitative measurement of cystatin C in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7040 FDA UDI
- Primary DI / UDI-DI
- 00842768006104 FDA UDI
- 510(k) Number
- K063351 FDA UDI
- FDA Product Code
- NDY FDA UDI
- GMDN Term
- Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Cystatin C IVD, kit, nephelometry/turbidimetry
DImension Vista® Cystatin C Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cystatin C IVD, kit, nephelometry/turbidimetry.
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- ADVIA Chemistry Cystatin C_2 Assay — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Cystatin C — Sentinel Ch. Srl · Class II
- Tina-quant Cystatin C Gen.2 — Roche Diagnostics Corp. · Class II
- Optilite Cystatin C Kit — The Binding Site Group · Class II
- Tina-quant Cystatin C Gen.2 — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 3b322603-6aec-495b-8942-7866991c0205 37 fields · synced May 30, 2026