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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 5 of 6

Device	Model / Reference	Registries	Class	Status
ImmunoCAP Rare Allergen Rf267, Cardamon	14-5058-10	FDA UDI	Class I	Active
EliA IgG Curve Control	83-0000-91	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf282, Nutmeg	14-5087-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx10, Food	14-4847-01	FDA UDI	Class II	Active
EliA IgG Conjugate	83-0000-11	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf212, Mushroom (champignon)	14-5086-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt213, Pine	14-5208-10	FDA UDI	Class I	Active
ImmunoCAP Allergen ex72, Cagebirds	14-4278-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k80, Formaldehyde/Formalin	14-4341-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rfx11, Vegetables	14-5177-10	FDA UDI	Class I	Active
ImmunoCAP Total IgE	10-9517-02	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf268, Clove	14-5064-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf346, Abalone	14-5283-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rm203, Trichosporon pullulans	14-5027-10	FDA UDI	Class I	Active
ImmunoCAP Allergen f57, Japanese millet	14-4461-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf315, Green bean	14-5211-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k86, Trimellitic anhydride, TMA	14-4369-10	FDA UDI	Class I	Active
ImmunoCAP Allergen tx3, Tree pollen	14-4271-01	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rt217, Peppertree	14-5167-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx9, Food	14-4846-01	FDA UDI	Class II	Active
ImmunoCAP Tryptase Calibrator Strip	34-2342-21	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf320, Crayfish	14-5219-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf308, Sardine (Pilchard)	14-5195-10	FDA UDI	Class I	Active
EliA dsDNA Positive Control 2500/5000	83-0045-31	FDA UDI	Class I	Active
ImmunoCAP Allergen Ri207, Cockroach, Oriental	14-5275-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt45, Cedar elm	14-4944-10	FDA UDI	Class I	Active
ImmunoCAP Allergen pax1	14-4350-01	FDA UDI	Class II	Active
ImmunoCAP Allergen k70, Green coffee bean	14-4363-01	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf333, Linseed	14-5250-10	FDA UDI	Class I	Active
ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH	10-9414-01	FDA UDI	Class I	Active
ImmunoCAP Total IgE Curve Controls	10-9257-01	FDA UDI	Class II	Active
ImmunoCAP Tryptase	10-9525-02	FDA UDI	Class II	Active
ImmunoCAP Specific IgG Calibrators	10-9305-01	FDA UDI	Class I	Active
ImmunoCAP Allergen k74, Silk	14-4333-01	FDA UDI	Class II	Active
ImmunoCAP Antigen RGm23, Thermoactinomyces vulgaris	14-5303-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k82, Latex	14-4511-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rt37, Bald cypress	14-4941-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf414, Tilapia	14-4937-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf234, Vanilla	14-5106-10	FDA UDI	Class I	Active
ImmunoCAP Allergen o70, Seminal fluid	14-4371-10	FDA UDI	Class I	Active
Quality Club Specific IgE	10-9298-01	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf340, Cochineal extract (Carmine red)	14-5268-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf289, Date	14-5068-10	FDA UDI	Class I	Active
ImmunoCAP Gliadin IgA/IgG Control Low	34-2332-41	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rw207, Lupin	14-5022-10	FDA UDI	Class I	Active
Quality Club ECP	10-9344-01	FDA UDI	Class I	Active
Development Solution	34-2247-36	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf264, Eel	14-5042-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf272, Tarragon	14-5103-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf283, Oregano	14-5088-10	FDA UDI	Class I	Active

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