Identity
- Trade Name
- EliA U1RNP Well EUDAMEDFDA UDI
- Generic Name
- U1-RNP antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA U1RNP EUDAMEDEliA U1RNP Well FDA UDI
- Model / Reference
- 14-5501-01 EUDAMEDDECC055010 FDA UDI
- Description
- EliA U1RNP Well FDA UDI
Identifiers
- Catalog Number
- DECC055010 FDA UDI
- Primary DI / UDI-DI
- 07333066014524 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0072M7 EUDAMED
- FDA Product Code
- LKJ FDA UDI
- EMDN Code
- W0102100114 U1-SNRNP - ANTIBODIES EUDAMED
- GMDN Term
- U1-RNP antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5100 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 U1RNP 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 | 7333066BUDI0072M7 | 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 5ef8453d-bd9a-40df-b696-e20f416803bf 61 fields · synced Jun 19, 2026
- FDA UDI 07674b88-9bf1-4c52-9719-cb0ed4cbb941 36 fields · synced May 30, 2026