ADVIA Centaur® H2n Calibrator
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® H2n Calibrator EUDAMEDFDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_REAG_H2n Cal EUDAMEDHER-2/Neu - CENTAUR - CAL - 2x2x2mL FDA UDI
- Model / Reference
- 10308993 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_REAG_H2n Cal EUDAMED
- Description
- HER-2/Neu - CENTAUR - CAL - 2x2x2mL FDA UDI
Identifiers
- Catalog Number
- 913551 FDA UDI
- Primary DI / UDI-DI
- 00630414471228 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901853W7 EUDAMED
- 510(k) Number
- K024017 FDA UDI
- FDA Product Code
- NCW FDA UDI
- EMDN Code
- W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6010 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator
ADVIA Centaur® H2n Calibrator by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator.
- Atellica IM H2n Calibrator — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K024017 also covers:
- ADVIA Centaur® H2n — Siemens Healthcare Diagnostics
- ADVIA Centaur® H2n MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® H2n QC — Siemens Healthcare Diagnostics
- Atellica IM H2n — Siemens Healthcare Diagnostics
- Atellica IM H2n Calibrator — Siemens Healthcare Diagnostics
- Atellica IM H2n MCM — Siemens Healthcare Diagnostics
- Atellica IM H2n QC — Siemens Healthcare Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 17eafef7-80c3-4802-bbd2-ec9ca35cf64e 37 fields · synced Jul 8, 2026
- EUDAMED 4666520e-f99a-4d2e-8232-b346ca685392 61 fields · synced Jul 8, 2026