ImmunoCAP Allergen f84, Kiwi fruit
EUDAMEDFDA UDIClass B (EU MDR)
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen f84, Kiwi fruit EUDAMEDFDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Allergen EUDAMEDImmunoCAP Allergen f84, Kiwi fruit FDA UDI
- Model / Reference
- 14-4295-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Allergen f84, Kiwi fruit FDA UDI
Identifiers
- Catalog Number
- 14-4295-01 FDA UDI
- Primary DI / UDI-DI
- 07333066002811 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0017LX EUDAMED
- 510(k) Number
- K051218 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 f84, Kiwi fruit 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 | 7333066BUDI0017LX | 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 f4e2c21c-b94a-40bd-8685-6c1f23a20a22 61 fields · synced Jul 9, 2026
- FDA UDI 626e3ebc-1af2-4ee6-b698-d3eae9684911 37 fields · synced May 30, 2026