Identity
- Trade Name
- ADVIA Centaur PBNPII FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T FDA UDI
- Model / Reference
- 11203759 FDA UDI
- Description
- NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T FDA UDI
Identifiers
- Catalog Number
- 11203759 FDA UDI
- Primary DI / UDI-DI
- 00630414284927 FDA UDI
- 510(k) Number
- K220265 FDA UDI
- FDA Product Code
- NBC FDA UDI
- GMDN Term
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1117 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
ADVIA Centaur PBNPII by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay.
- Elecsys ProBNP II — Roche Diagnostics Corp. · Class II
- Elecsys proBNP II STAT Immunoassay — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Elecsys proBNP II — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ARCHITECT — Abbott · 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 4665aa86-c046-4836-827b-aefa48511dbc 37 fields · synced May 31, 2026