EliA IgG Calibrator Strips
EUDAMEDFDA UDIClass B (EU MDR)
by Phadia AB
Identity
- Trade Name
- EliA IgG Calibrator Strips EUDAMEDEliA IgG Calibrator Strip FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EliA IgG Method Reagents EUDAMEDEliA IgG Calibrator Strip FDA UDI
- Model / Reference
- 83-1015-01 EUDAMED83-0002-91 FDA UDI
- Description
- EliA IgG Calibrator Strip FDA UDI
Identifiers
- Catalog Number
- 83-0002-91 FDA UDI
- Primary DI / UDI-DI
- 07333066012797 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0043LY EUDAMED
- FDA Product Code
- NHX FDA UDI
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5775 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
EliA IgG Calibrator Strips by Phadia AB — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0043LY | 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 20dc8ce6-f3dc-43f2-adaa-b9af12b5fbf4 61 fields · synced Jun 17, 2026
- FDA UDI 561928ef-b24f-4662-ab96-4b0adc06c730 36 fields · synced May 30, 2026