Identity
- Trade Name
- Elecsys proBNP II STAT Immunoassay FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- proBNP G2 STAT Elecsys cobas e 100 V2.1 FDA UDI
- Model / Reference
- 09315276160 FDA UDI
- Description
- proBNP G2 STAT Elecsys cobas e 100 V2.1 FDA UDI
Identifiers
- Catalog Number
- 09315276160 FDA UDI
- Primary DI / UDI-DI
- 07613336191576 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
Yes
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
Elecsys proBNP II STAT Immunoassay by Roche Diagnostics Corp. — 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.
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- Atellica IM BNP — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
K210546 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 90e0afb8-4cfa-4763-9066-642e1967990e 35 fields · synced Jun 8, 2026