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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 2 of 6

Device	Model / Reference	Registries	Class	Status
ImmunoCAP Allergen Rgx6, Grass pollen	14-5200-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re209, Gerbil epithelium	14-5015-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rm204, Ulocladium chartarum	14-5028-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt201, Spruce	14-5005-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rk208, Allergen component nGal d 4 Lysozyme, Egg	14-5128-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rm209, Penicillium glabrum	14-5203-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Ri206, Cockroach, American	14-5274-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf410, Grouper	14-4933-10	FDA UDI	Class I	Active
ImmunoCAP Allergen m70, Pityrosporum orbiculare	14-4349-01	FDA UDI	Class II	Active
ImmunoCAP Allergen o215, Component nGal-alpha-1, 3-Gal (alpha-Gal) Thyroglobulin,	14-5997-02	FDA UDI	Class II	Active
ImmunoCAP Thyroglobulin IgG Antibodies Control NLH	10-9413-01	FDA UDI	Class I	Active
ImmunoCAP Autoimmunity Specific IgG Sample Diluent	34-2316-11	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf211, Blackberry	14-5051-10	FDA UDI	Class I	Active
EliA CoV Positive Control C1 250	83-0042-11	FDA UDI	N	Active
ImmunoCAP Rare Allergen Rf219, Fennel seed	14-5070-10	FDA UDI	Class I	Active
EliA CCP Positive Control 100	83-0007-11	FDA UDI	Class II	Active
ImmunoCAP Allergen Rm210, Trichophyton ment. var goetzii	14-5223-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf319, Beetroot	14-5216-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf301, Persimon (kaki fruit, sharon)	14-5161-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rfx17, Fruits	14-5179-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Ri205, Bumble bee	14-5270-10	FDA UDI	Class I	Active
EliA Scl-70 Well	DECC055060	FDA UDI	Class II	Active
EliA SmDP Well	DECC056240	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf246, Guar, guar gum	14-5076-10	FDA UDI	Class I	Active
ImmunoCAP Antigen RGm24, Stachybotrys atra	14-5304-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt218, Virginia live oak	14-5252-10	FDA UDI	Class I	Active
ImmunoCAP Allergen wx209, Ambrosia sp.	14-5026-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rm46, Bipolaris	14-4940-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re211, Rabbit, urine proteins	14-5034-10	FDA UDI	Class I	Active
ImmunoCAP Allergen pax3	14-4352-01	FDA UDI	Class II	Active
ImmunoCAP Specific IgE Calibrators 0-100	10-9460-01	FDA UDI	Class II	Active
Phadia Information Data Manager Software Package	12-3801-11	FDA UDI	Class II	Active
EliA APS Positive Control 100	83-0007-91	FDA UDI	Class I	Active
ImmunoCAP Allergen Ri204, Horse fly	14-5207-10	FDA UDI	Class I	Active
EliA IgG/IgM/IgA Negative Control 100	83-0007-31	FDA UDI	Class I	Active
ImmunoCAP Allergen ex73, Feathers	14-4828-01	FDA UDI	Class II	Active
EliA Gliadin IgA Well	DECC055190	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf324, Hop	14-5228-10	FDA UDI	Class I	Active
ImmunoCAP Allergen c7, Cefaclor	14-5336-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rk210, Maleic anhydrid	14-5190-10	FDA UDI	Class I	Active
ImmunoCAP Tryptase Calibrator Strip	34-2272-91	FDA UDI	Class II	Active
ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase	14-4508-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf247, Honey	14-5078-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgG Curve Controls	10-9333-01	FDA UDI	Class I	Active
ImmunoCAP Allergen Rm221, Allergen component rAsp f 4 Aspergillus fumigatus	14-5296-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Ro201, Tobacco leaf	14-5136-10	FDA UDI	Class I	Active
Quality Club Total IgE	10-9297-01	FDA UDI	Class I	Active
ImmunoCAP Allergen Rtx10, Tree pollen	14-5183-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf220, Cinnamon	14-5063-10	FDA UDI	Class I	Active
ImmunoCAP Allergen f253, Pine nut, pignoles	14-5093-10	FDA UDI	Class I	Active

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