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ImmunoCAP Total IgE Conjugate 400
EUDAMEDFDA UDIClass B (EU MDR)
Ref 10-9480-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Total IgE Conjugate 400 EUDAMEDFDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Total IgE EUDAMEDImmunoCAP Total IgE Conjugate 400 FDA UDI
- Model / Reference
- 10-9480-01 EUDAMED34-2325-42 FDA UDI
- Description
- ImmunoCAP Total IgE Conjugate 400 FDA UDI
Identifiers
- Catalog Number
- 34-2325-42 FDA UDI
- Primary DI / UDI-DI
- 07333066019864 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0059MF 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
Yes
EUDAMED
Microbial Substances
Yes
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 Conjugate 400 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 | 7333066BUDI0059MF | 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 517f57d1-fcd3-40fa-883c-d3aab4b7779f 61 fields · synced Jun 18, 2026
- FDA UDI 19e31e26-5067-417a-b4fa-2dd3445098da 37 fields · synced May 30, 2026