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ImmunoCAP Allergen o215, Component nGal-alpha-1, 3-Gal (alpha-Gal) Thyroglobuli…
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref 14-5997-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine EUDAMED
- Device Name
- ImmunoCAP Allergen EUDAMED
- Model / Reference
- 14-5997-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066011080 EUDAMED
- Basic UDI-DI
- 7333066BUDI0019M3 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
ImmunoCAP Allergen o215, Component nGal-alpha-1, 3-Gal (alpha-Gal) Thyroglobuli… by Phadia AB — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k)
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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 | K200279 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0019M3 | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED e1b1a789-3e87-4d86-812a-078c06cafc13 61 fields · synced Jul 20, 2026
- FDA 510(k) K200279 1 fields · synced May 18, 2026