ADVIA Centaur® BNP
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® BNP EUDAMEDFDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_BNP EUDAMEDBNP - CENTAUR - RGT - 500 tests FDA UDIBNP - CENTAUR - RGT - 100 tests FDA UDI
- Model / Reference
- 10309045 EUDAMEDFDA UDI10309044 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_BNP EUDAMED
- Description
- BNP - CENTAUR - RGT - 500 tests FDA UDIBNP - CENTAUR - RGT - 100 tests FDA UDI
Identifiers
- Catalog Number
- 2816634 FDA UDI2816138 FDA UDI
- Primary DI / UDI-DI
- 00630414472812 EUDAMEDFDA UDI00630414472805 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900805VM EUDAMED
- Unit of Use DI
- 00630414003023 EUDAMED
- 510(k) Number
- K031038 FDA UDI
- FDA Product Code
- NBC FDA UDI
- EMDN Code
- W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
- GMDN Term
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1117 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
No
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
ADVIA Centaur® BNP by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay.
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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 (4)
- FDA UDI 812b671d-b731-4790-aa68-9f0c66a43b54 36 fields · synced Oct 6, 2026
- FDA UDI b7d925c7-c8be-456d-9bcb-335f99094fdc 37 fields · synced May 30, 2026
- EUDAMED 4d4292bc-4353-44d6-9a64-aae517e9731a 61 fields · synced Jul 18, 2026
- EUDAMED 55f76f3e-ef26-43ee-afc7-1de5de7decbe 61 fields · synced Jul 28, 2026