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ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat

Phadia AB · Model 14-4954-01 · UDI-DI 07333066005454

DHB Prescription
1
510(k) clearances
60
Adverse events
27
Recalls
16
Facilities

Description

ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.