← Back to catalogue
EliA ß2-Glycoprotein I IgM Well
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-5533-01
by Phadia AB
Identity
- Trade Name
- EliA ß2-Glycoprotein I IgM Well EUDAMEDFDA UDI
- Generic Name
- Beta-2-glycoprotein I antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA β2-Glycoprotein I IgM EUDAMEDEliA ß2-Glycoprotein I IgM Well FDA UDI
- Model / Reference
- 14-5533-01 EUDAMEDDECC055330 FDA UDI
- Description
- EliA ß2-Glycoprotein I IgM Well FDA UDI
Identifiers
- Catalog Number
- DECC055330 FDA UDI
- Primary DI / UDI-DI
- 07333066014760 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0097MP EUDAMED
- 510(k) Number
- K091845 FDA UDI
- FDA Product Code
- MSV FDA UDI
- EMDN Code
- W0102100503 ANTI-B2-GLYCOPROTEIN I ANTIBODIES EUDAMED
- GMDN Term
- Beta-2-glycoprotein I 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
Yes
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 ß2-Glycoprotein I IgM 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 | 7333066BUDI0097MP | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED c302ddb8-5025-4470-94ce-b8344a219b68 61 fields · synced Jul 9, 2026
- FDA UDI 5d5c8f30-b96f-4b54-80a4-1db0db5856b6 37 fields · synced May 29, 2026