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Phadia GmbH

Last updated May 24, 2026

What Phadia GmbH makes

Phadia GmbH develops in vitro diagnostic (IVD) kits and reagents for measuring allergen-specific immunoglobulin E (IgE) antibodies, total immunoglobulin levels (IgA, IgE, IgG), and mast cell protease. Their products include enzyme immunoassay (EIA) and fluorescent immunoassay kits for detecting specific antibodies, such as gliadin antibodies, as well as controls and conjugates for plasma protein and autoimmunity testing. The portfolio also covers allergen-specific reagents for identifying sensitivities to substances like dog fennel, basil, and specific molds. Additional offerings include sample diluents and well components for laboratory use in allergy and autoimmunity diagnostics.

The company’s IVD products are regulated under Class I and Class II classifications in the US, with some devices falling under the Not Classified (N) category. These devices are listed via the FDA’s 510(k) and UDI (Unique Device Identification) systems. Phadia GmbH operates from the United States, adhering to regulatory frameworks governing in vitro diagnostic medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
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Catalogue (273)

Page 6 of 6

Device	Model / Reference	Registries	Class	Status
ImmunoCAP Allergen Rf329, Watermelon	14-5245-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf227, Sugar-beet seed	14-5102-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf206, Mackerel	14-5019-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf415, Walleye pike	14-4938-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf262, Aubergine, eggplant	14-5047-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rfx21, Fruits	14-5206-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re206, Rabbit serum proteins	14-5033-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf286, Mare's milk	14-5109-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf300, Goat milk	14-5144-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf347, Quinoa	14-5284-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf343, Raspberry	14-5280-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf345, Macadamia nut	14-5282-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf277, Dill	14-5069-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf298, Tragacanth	14-5139-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt56, Bayberry	14-4947-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re219, Chicken serum proteins	14-5230-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf316, Rape seed	14-5213-10	FDA UDI	Class I	Active
EliA SARS-CoV-2-Sp1 IgG Well	DECC066630	FDA UDI	N	Active
EliA Gliadin IgG Well	DECC055200	FDA UDI	Class II	Active
ImmunoCAP Allergen Rw204, Sunflower	14-5025-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf279, Chilipepper	14-5062-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rt211, Sweet gum	14-5155-10	FDA UDI	Class I	Active
Elia Scl-70s Immunoassay	K140493	FDA 510(k)	Class II	Active

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