Identity
- Trade Name
- ADVIA Centaur® CsA CAL FDA UDI
- Generic Name
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator FDA UDI
- Device Name
- Cyclosporine - CENTAUR - CAL - 2x2x2mL FDA UDI
- Model / Reference
- 10335454 FDA UDI
- Description
- Cyclosporine - CENTAUR - CAL - 2x2x2mL FDA UDI
Identifiers
- Catalog Number
- 4567682 FDA UDI
- Primary DI / UDI-DI
- 00630414524481 FDA UDI
- 510(k) Number
- K071455 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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: Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
ADVIA Centaur® CsA CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator.
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Cyclosporine Calibrator 0 ng/mL — Roche Diagnostics Corp. · Class II
- Cyclosporine Calibrators — Roche Diagnostics Corp. · Class II
- Atellica IM CsA Calibrator — Siemens Healthcare Diagnostics · Class II
- Syva® Emit® 2000 Cyclosporine Specific Calibrators — Siemens Healthcare Diagnostics · Class II
- Dimension® CSA Calibrator — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K071455 also covers:
- ADVIA Centaur® CsA — Siemens Healthcare Diagnostics
- ADVIA Centaur® CsA PRE Pretreatment — Siemens Healthcare Diagnostics
- ADVIA Centaur® Multi-Diluent 12 — Siemens Healthcare Diagnostics
- Atellica IM CsA — Siemens Healthcare Diagnostics
- Atellica IM CsA Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CsA PRE Pretreatment — Siemens Healthcare Diagnostics
- Atellica IM Multi-Diluent 12 — Siemens Healthcare Diagnostics
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 9a14f399-588f-489a-9aeb-42c783b463c7 37 fields · synced May 30, 2026