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ImmunoCAP Allergen i3, Common wasp venom (Yellow jacket)
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 14-4525-01510(k) K123275
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen i3, Common wasp venom (Yellow jacket) EUDAMEDFDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Allergen EUDAMEDImmunoCAP Allergen i3, Common wasp venom (Yellow jacket) FDA UDI
- Model / Reference
- 14-4525-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Allergen i3, Common wasp venom (Yellow jacket) FDA UDI
Identifiers
- Catalog Number
- 14-4525-01 FDA UDI
- Primary DI / UDI-DI
- 07333066004136 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0017LX EUDAMED
- 510(k) Number
- K123275 FDA UDI
- FDA Product Code
- DHB FDA UDI
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5750 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 Allergen i3, Common wasp venom (Yellow jacket) by Phadia AB — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123275 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0017LX | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (3)
- EUDAMED 3b92f633-89d6-4817-9d69-6bf9c529d26d 85 fields · synced Jun 18, 2026
- FDA UDI deeae200-f64c-4ec1-a4b9-747d66761bb1 37 fields · synced May 29, 2026
- FDA 510(k) K123275 1 fields · synced Jun 9, 2026