Identity
- Trade Name
- Atellica IM BNP Calibrator FDA UDI
- Generic Name
- B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator FDA UDI
- Device Name
- BNP - Atellica IM - CAL - (2 PK) 2 x 2 x 2.0 mL FDA UDI
- Model / Reference
- 10995473 FDA UDI
- Description
- BNP - Atellica IM - CAL - (2 PK) 2 x 2 x 2.0 mL FDA UDI
Identifiers
- Catalog Number
- 10995473 FDA UDI
- Primary DI / UDI-DI
- 00630414598000 FDA UDI
- 510(k) Number
- K031038 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
Atellica IM BNP Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator.
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
- ARCHITECT — Abbott · Class II
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- ARCHITECT — Abbott · Class II
Cleared under the same submission
K031038 also covers:
- ADVIA Centaur® ACS:180® Systems BNP 1, 2, 3 QC — Siemens Healthcare Diagnostics
- ADVIA Centaur® BNP MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems ACS:180® Systems BNP Calibrator — Siemens Healthcare Diagnostics
- Atellica IM BNP — Siemens Healthcare Diagnostics
- Atellica IM BNP — Siemens Healthcare Diagnostics
- Atellica IM BNP MCM — Siemens Healthcare Diagnostics
- Atellica IM BNP QC — Siemens Healthcare Diagnostics
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 ab12b8dc-eaae-4bb5-a071-47c884d9e21c 37 fields · synced May 30, 2026