Identity
- Trade Name
- Atellica IM Calibrator C FDA UDI
- Generic Name
- Multiple anaemia-related analyte IVD, calibrator FDA UDI
- Device Name
- Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL FDA UDI
- Model / Reference
- 11206243 FDA UDI
- Description
- Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 11206243 FDA UDI
- Primary DI / UDI-DI
- 00630414293554 FDA UDI
- 510(k) Number
- K993571 FDA UDI
- FDA Product Code
- CDD FDA UDI
- GMDN Term
- Multiple anaemia-related analyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1810 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: Multiple anaemia-related analyte IVD, calibrator
Atellica IM Calibrator C by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple anaemia-related analyte IVD, calibrator.
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics · Class II
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator C — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics · Class II
- Dimension® ANEM CAL — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K993571 also covers:
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems Calibrator C — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 +C — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 DTT/Releasing Agent — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 Diluent — Siemens Healthcare Diagnostics
- ADVIA Centaur® VB12 MCM — Siemens Healthcare Diagnostics
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics
- Atellica IM Calibrator C — Siemens Healthcare Diagnostics
- Atellica IM VB12 — 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 7f57197c-4d3d-4758-a947-1082905efdf8 37 fields · synced Jun 6, 2026