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EliA IgG/IgM/IgA Negative Control 250
EUDAMEDFDA UDIClass B (EU MDR)
Ref 83-1037-01
by Phadia AB
Identity
- Trade Name
- EliA IgG/IgM/IgA Negative Control 250 EUDAMEDFDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- EliA Control EUDAMEDEliA IgG/IgM/IgA Negative Control 250 FDA UDI
- Model / Reference
- 83-1037-01 EUDAMED83-0006-81 FDA UDI
- Description
- EliA IgG/IgM/IgA Negative Control 250 FDA UDI
Identifiers
- Catalog Number
- 83-0006-81 FDA UDI
- Primary DI / UDI-DI
- 07333066013039 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0047M8 EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Plasma protein IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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 IgG/IgM/IgA Negative Control 250 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 | 7333066BUDI0047M8 | 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 42912237-1bde-4ec0-9b91-fec6a1c4ce2a 61 fields · synced Jun 18, 2026
- FDA UDI 059ca8d2-ebd3-4854-975d-496e599d7da9 36 fields · synced May 30, 2026