Identity
- Trade Name
- Dimension Vista® ALPI CAL FDA UDI
- Generic Name
- Alkaline phosphatase (ALP) isoenzyme IVD, calibrator FDA UDI
- Device Name
- Alkaline Phosphatase Calibrator, 3 x 1mL FDA UDI
- Model / Reference
- 10714029 FDA UDI
- Description
- Alkaline Phosphatase Calibrator, 3 x 1mL FDA UDI
Identifiers
- Catalog Number
- KC331 FDA UDI
- Primary DI / UDI-DI
- 00842768039041 FDA UDI
- 510(k) Number
- K122323 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Alkaline phosphatase (ALP) isoenzyme 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: Alkaline phosphatase (ALP) isoenzyme IVD, calibrator
Dimension Vista® ALPI CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alkaline phosphatase (ALP) isoenzyme IVD, calibrator.
- Dimension® ALPI CAL — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K122323 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
Sources (1)
- FDA UDI f9ab9619-d3e5-46ef-9bde-6b3e515a8610 37 fields · synced May 31, 2026