Identity
- Trade Name
- DImension Vista® Apolipoprotein Calibrator FDA UDI
- Generic Name
- Plasma protein IVD, calibrator FDA UDI
- Device Name
- For the calibration of APOAI and APOB methods on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445922 FDA UDI
- Description
- For the calibration of APOAI and APOB methods on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- KC720 FDA UDI
- Primary DI / UDI-DI
- 00842768006364 FDA UDI
- 510(k) Number
- K063608 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Plasma protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: Plasma protein IVD, calibrator
DImension Vista® Apolipoprotein Calibrator by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K063608 also covers:
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 45cd3f3e-636e-4dc0-9835-23232262cd25 37 fields · synced May 29, 2026