ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog EUDAMEDFDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Allergen EUDAMEDImmunoCAP Allergen e229, Allergen component rCan f 4 Dog FDA UDI
- Model / Reference
- 14-5755-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog FDA UDI
Identifiers
- Catalog Number
- 14-5755-01 FDA UDI
- Primary DI / UDI-DI
- 07333066011011 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0017LX EUDAMED
- 510(k) Number
- K190315 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
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: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
ImmunoCAP Allergen e229, Allergen component rCan f 4 Dog by Phadia AB — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190315 | 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 9075875a-0c27-4ca2-9b2e-518ca6b862ce 61 fields · synced Aug 1, 2026
- FDA UDI 1f4ed776-5b05-4ac8-853c-64fe0b11178b 37 fields · synced May 30, 2026
- FDA 510(k) K190315 1 fields · synced May 18, 2026