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EliA Cardiolipin IgA Well
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-5528-01
by Phadia AB
Identity
- Trade Name
- EliA Cardiolipin IgA Well EUDAMEDFDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA Cardiolipin IgA EUDAMEDEliA Cardiolipin IgA Well FDA UDI
- Model / Reference
- 14-5528-01 EUDAMEDDECC055280 FDA UDI
- Description
- EliA Cardiolipin IgA Well FDA UDI
Identifiers
- Catalog Number
- DECC055280 FDA UDI
- Primary DI / UDI-DI
- 07333066014715 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0092MD EUDAMED
- FDA Product Code
- MID FDA UDI
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
- GMDN Term
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
EliA Cardiolipin IgA Well by Phadia AB — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0092MD | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED 46518584-40f4-4e67-a905-9b73ee44deb0 61 fields · synced Jun 19, 2026
- FDA UDI ceb060ab-0e05-4cbe-b962-5d3bfe230267 36 fields · synced May 29, 2026