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ImmunoCAP Total IgE Anti-IgE
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-4509-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Total IgE Anti-IgE EUDAMEDFDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Total IgE EUDAMEDImmunoCAP Total IgE Anti-IgE FDA UDI
- Model / Reference
- 14-4509-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Total IgE Anti-IgE FDA UDI
Identifiers
- Catalog Number
- 14-4509-01 FDA UDI
- Primary DI / UDI-DI
- 07333066004037 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0062M4 EUDAMED
- 510(k) Number
- K133404 FDA UDI
- FDA Product Code
- DGC FDA UDI
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
- GMDN Term
- Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 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
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
ImmunoCAP Total IgE Anti-IgE 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 | 7333066BUDI0062M4 | 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 7b1b9cad-31ac-43e8-883d-fc7c8461c9d3 61 fields · synced May 30, 2026
- FDA UDI c2c62005-2d76-4615-910d-0b28e0ee0c44 37 fields · synced May 30, 2026