Identity
- Trade Name
- ADVIA Centaur® FER MCM FDA UDI
- Generic Name
- Ferritin IVD, control FDA UDI
- Device Name
- Ferritin Master Curve Material Set - CENTAUR - CONS FDA UDI
- Model / Reference
- 10311616 FDA UDI
- Description
- Ferritin Master Curve Material Set - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 672416000 FDA UDI
- Primary DI / UDI-DI
- 00630414126197 FDA UDI
- 510(k) Number
- K143376 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Ferritin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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: Ferritin IVD, control
ADVIA Centaur® FER MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, control.
- IMMULITE® Systems FER Calibration Verification Material Ferritin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- AIA-PACK FER Calibration Verification Test Set — Tosoh Corp. · Class II
- Alinity — ABBOTT IRELAND · Class I
- Diazyme — Diazyme Laboratories, Inc.
- VITROS — Ortho-Clinical Diagnostics · Class I
- Atellica IM Fer MCM — Siemens Healthcare Diagnostics · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b78bb58e-7d17-426d-ae3d-102fcdcfa5d3 37 fields · synced May 31, 2026