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EliA Celikey IgA Well
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-5517-01
by Phadia AB
Identity
- Trade Name
- EliA Celikey IgA Well EUDAMEDFDA UDI
- Generic Name
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EliA Celikey IgA EUDAMEDEliA Celikey IgA Well FDA UDI
- Model / Reference
- 14-5517-01 EUDAMEDDECC055170 FDA UDI
- Description
- EliA Celikey IgA Well FDA UDI
Identifiers
- Catalog Number
- DECC055170 FDA UDI
- Primary DI / UDI-DI
- 07333066014661 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0085MG EUDAMED
- 510(k) Number
- K062787 FDA UDI
- FDA Product Code
- MVM FDA UDI
- EMDN Code
- W0102100601 TISSUE TRANSGLUTAMINASE ANTIBODIES EUDAMED
- GMDN Term
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA) 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 Celikey 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 | 7333066BUDI0085MG | 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 cc689116-9a1f-4969-853f-51fae9aa0586 61 fields · synced May 30, 2026
- FDA UDI f5077b1f-b175-4ede-b649-0db292fbd7d5 37 fields · synced May 30, 2026