ImmunoCAP Allergen fx25, Food
EUDAMEDFDA UDIClass B (EU MDR)
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen fx25, Food EUDAMEDFDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Allergen EUDAMEDImmunoCAP Allergen fx25, Food FDA UDI
- Model / Reference
- 14-4857-01 EUDAMEDFDA UDI
- Description
- ImmunoCAP Allergen fx25, Food FDA UDI
Identifiers
- Catalog Number
- 14-4857-01 FDA UDI
- Primary DI / UDI-DI
- 07333066004693 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0018LZ 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
Yes
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
Immunology is the branch of science that studies how our immune system detects, identifies, and eliminates foreign substances or diseases. The ImmunoCAP Allergen fx25, Food is a medical device designed to detect and measure allergens in food products, providing valuable information for individuals with allergies and those who want to minimize their exposure to potential allergens. This device uses immunological methods to identify specific allergens present in a sample of food, allowing users to take control of their health and well-being.
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- IMMULITE®2000 Systems 3gAllergy™ Weed Panel 3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0018LZ | 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 145b86bd-6832-4b7f-8f21-d79f3304e790 61 fields · synced Aug 1, 2026
- FDA UDI b4f9a04d-0075-4aff-a376-952b7c8dae01 37 fields · synced May 30, 2026