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EliA APS Positive Control 250
EUDAMEDFDA UDIClass B (EU MDR)
Ref 83-1055-01
by Phadia AB
Identity
- Trade Name
- EliA APS Positive Control 250 EUDAMEDFDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- EliA Control EUDAMEDEliA APS Positive Control 250 FDA UDI
- Model / Reference
- 83-1055-01 EUDAMED83-0008-01 FDA UDI
- Description
- EliA APS Positive Control 250 FDA UDI
Identifiers
- Catalog Number
- 83-0008-01 FDA UDI
- Primary DI / UDI-DI
- 07333066019994 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0020LL EUDAMED
- 510(k) Number
- K091845 FDA UDI
- 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
No
EUDAMED
Animal Tissues
No
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 APS Positive 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 | 7333066BUDI0020LL | 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 ffc21f80-6ef6-4ba6-b405-960d8bdb0a37 61 fields · synced Jul 15, 2026
- FDA UDI d7038053-fbda-4c74-af1e-22ac7c322d94 37 fields · synced May 30, 2026