Identity
- Trade Name
- ADVIA Centaur® Systems CA 125II Calibrator FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, calibrator FDA UDI
- Device Name
- CA125 - CENTAUR - CAL - 2x2x2mL FDA UDI
- Model / Reference
- 10310444 FDA UDI
- Description
- CA125 - CENTAUR - CAL - 2x2x2mL FDA UDI
Identifiers
- Catalog Number
- 128536 FDA UDI
- Primary DI / UDI-DI
- 00630414461335 FDA UDI
- 510(k) Number
- K020828 FDA UDI
- FDA Product Code
- LTK FDA UDI
- GMDN Term
- Cancer antigen 125 (CA125) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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: Cancer antigen 125 (CA125) IVD, calibrator
ADVIA Centaur® Systems CA 125II Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 125 (CA125) IVD, calibrator.
- AIA-PACK CA 125 Calibrator Set — Tosoh Corp. · Class II
- Lumipulse G CA125II Calibrators — FUJIREBIO INC. · Class II
- Elecsys CA 125 II Calset — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class II
- Alinity — Abbott · Class II
- Elecsys CA 125 II CalSet II — Roche Diagnostics Corp. · Class II
- Atellica IM CA 125II Calibrator — Siemens Healthcare Diagnostics · 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
Sources (1)
- FDA UDI fb8afe69-6252-4c44-a183-654c0fc7d2b6 37 fields · synced May 30, 2026