Identity
- Trade Name
- Dimension Vista® PNBP CAL FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator FDA UDI
- Device Name
- N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL FDA UDI
- Model / Reference
- 10464322 FDA UDI
- Description
- N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL FDA UDI
Identifiers
- Catalog Number
- KC676A FDA UDI
- Primary DI / UDI-DI
- 00842768025129 FDA UDI
- 510(k) Number
- K080578 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
Dimension Vista® PNBP CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080578 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI ca951954-752b-40d3-99f7-f1d5ee8e9493 37 fields · synced May 30, 2026