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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 1 of 6

Device	Model / Reference	Registries	Class	Status
EliA Sample Diluent	83-0000-21	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf337, Sole	14-5256-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgA Conjugate	34-2328-11	FDA UDI	Class II	Active
EliA ANA 3 Positive Control 250	83-0041-11	FDA UDI	Class I	Active
ImmunoCAP Allergen Rw46, Dog fennel	14-4952-10	FDA UDI	Class I	Active
ImmunoCAP Autoimmunity Specific IgG Sample Diluent	34-2325-31	FDA UDI	Class I	Active
EliA IgM Conjugate	83-0004-91	FDA UDI	Class I	Active
EliA Symphony Well	DECC055080	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf297, Gum arabic	14-5138-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf269, Basil	14-5048-10	FDA UDI	Class I	Active
ImmunoCAP Allergen i72, Green nimitti	14-4361-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rm208, Chaetomium globosum	14-5202-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rfx22, Nuts	14-5212-10	FDA UDI	Class I	Active
Quality Club EliA Autoimmunity	83-1006-01	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rt214, Date	14-5218-10	FDA UDI	Class I	Active
EliA Sm Well	DECC055020	FDA UDI	Class II	Active
ImmunoCAP Allergen pax6	14-4355-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf302, Mandarin (tangerine, clementine, satsumas)	14-5160-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rrx1, Regional	14-5193-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf273, Thyme	14-5105-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf413, Pollock	14-4936-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf303, Halibut	14-5158-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf342, Olive	14-5279-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt54, Russian olive	14-4945-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf339, Allspice	14-5267-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt57, Red cedar	14-4948-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rw23, Yellow dock	14-4950-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin	14-4507-01	FDA UDI	Class II	Active
ImmunoCAP Phadiatop	14-4338-01	FDA UDI	Class II	Active
ImmunoCAP Allergen f224, Poppy seed	14-5097-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx71, Spices	14-4358-10	FDA UDI	Class I	Active
EliA IgM Curve Control	83-0006-01	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf287, Red kidney bean	14-5100-10	FDA UDI	Class I	Active
ImmunoCAP Antigen RGe92, Parrot serum proteins, feathers and droppings	14-5317-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt205, Elder	14-5002-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx70, Spices	14-4357-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgE 0-100	10-9462-02	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf318, Jack fruit	14-5215-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf322, Red currant	14-5221-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf217, Brussel sprouts	14-5054-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt209, Horn beam	14-5148-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf281, Curry (Santa Maria)	14-5067-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf384, Whitefish (Inconnu)	14-4932-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgA/IgG Sample Diluent	34-2293-41	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen f226, Pumpkin seed	14-5098-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rw82, Careless weed	14-4953-10	FDA UDI	Class I	Active
ImmunoCAP Tryptase Curve Control Strip	34-2273-51	FDA UDI	Class II	Active
ImmunoCAP Allergen pax5	14-4354-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf325, Sheep milk	14-5237-10	FDA UDI	Class I	Active
EliA IgA Calibrators	83-1013-01	FDA UDI	Class II	Active

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