Identity
- Trade Name
- EliA RF IgA Well EUDAMEDFDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA RF IgA EUDAMEDEliA RF IgA Well FDA UDI
- Model / Reference
- 14-5601-01 EUDAMEDDECC056010 FDA UDI
- Description
- EliA RF IgA Well FDA UDI
Identifiers
- Catalog Number
- DECC056010 FDA UDI
- Primary DI / UDI-DI
- 07333066014821 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0107LZ EUDAMED
- 510(k) Number
- K102673 FDA UDI
- FDA Product Code
- DHR FDA UDI
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMED
- GMDN Term
- Rheumatoid factor IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5775 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 RF 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 | 7333066BUDI0107LZ | 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 33ece21e-41d6-4fe8-952c-5ffe53259a18 61 fields · synced Jun 18, 2026
- FDA UDI 87859648-fff7-4a8a-b710-24cb5e7bd322 37 fields · synced May 30, 2026