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EliA IgA Calibrator Well
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-6616-01Ref 14-5516-01
by Phadia AB
Identity
- Trade Name
- EliA IgA Calibrator Well EUDAMEDFDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EliA IgA Method Reagents EUDAMEDEliA IgA Calibrator Well FDA UDI
- Model / Reference
- 14-6616-01 EUDAMED14-5516-01 EUDAMEDDECC055160 FDA UDI
- Description
- EliA IgA Calibrator Well FDA UDI
Identifiers
- Catalog Number
- DECC055160 FDA UDI
- Primary DI / UDI-DI
- 07333066024240 EUDAMED07333066014654 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0082MA EUDAMED
- 510(k) Number
- K062787 FDA UDI
- FDA Product Code
- MVM FDA UDI
- EMDN Code
- W0102010101 IMMUNOGLOBULIN A EUDAMED
- GMDN Term
- Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA) 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
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 IgA Calibrator 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 | 7333066BUDI0082MA | 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 (3)
- EUDAMED 170ac308-13da-4dc4-9922-6e7c7b24f859 61 fields · synced Jul 9, 2026
- EUDAMED 8f2cd5b2-b088-49bc-aee8-bda840c68dc6 61 fields · synced May 18, 2026
- FDA UDI 318bcba7-a595-484b-b91f-3fffcd5a8ec6 37 fields · synced May 30, 2026