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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 4 of 6

Device	Model / Reference	Registries	Class	Status
ImmunoCAP Allergen Rf341, Cranberry	14-5269-10	FDA UDI	Class I	Active
ImmunoCAP Tryptase Curve Control 1	34-2342-91	FDA UDI	Class II	Active
ImmunoCAP Tryptase Calibrators	10-9526-01	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf305, Fenugreek	14-5187-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf314, Snail	14-5210-10	FDA UDI	Class I	Active
ImmunoCAP Total IgE Calibrators	10-9252-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf291, Cauliflower	14-5060-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt41, White hickory	14-4942-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf306, Lime	14-5188-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt71, Red mulberry	14-4949-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rc208, Tetanus toxoid	14-5227-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf332, Mint	14-5249-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgA Calibrators	10-9304-01	FDA UDI	Class II	Active
Maintenance Solution Kit	10-9476-01	FDA UDI	Class I	Active
ImmunoCAP Allergen Rc206, ACTH (Adrenochorticotrophic hormone)	14-5162-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf311, Megrim	14-5204-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf261, Asparagus	14-5046-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rm211, Trichophyton ment. var interdigitale	14-5224-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf147, Gulf flounder	14-4928-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx74, Fish	14-4827-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k73, Silk waste	14-4400-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf271, Anise	14-5044-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf304, Langust (spiny lobster)	14-5159-10	FDA UDI	Class I	Active
ImmunoCAP Antigen RGm22, Micropolyspora faeni	14-5302-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf263, Green pepper (unripe seed)	14-5075-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k71, Castor bean	14-4364-01	FDA UDI	Class II	Active
EliA ANA 3 Positive Control 2500/5000	83-0041-21	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rm201, Tilletia tritici (Ustilago tritici)	14-5029-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen f294, Passion fruit	14-5091-10	FDA UDI	Class I	Active
EliA IgM Calibrators	83-1049-01	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid	14-5189-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rw45, Alfalfa	14-4951-10	FDA UDI	Class I	Active
EliA Celiac Positive Control 100	83-0007-21	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf42, Haddock	14-4939-10	FDA UDI	Class I	Active
ImmunoCAP Tryptase Curve Control 1	34-2311-12	FDA UDI	Class II	Active
ImmunoCAP Gliadin IgA Control High	34-2332-51	FDA UDI	Class II	Active
Phadia 100	12-3500-02	FDA UDI	Class II	Active
ImmunoCAP Allergen e7, Pigeon droppings	14-4168-01	FDA UDI	Class II	Active
ImmunoCAP Antigen AGf98, Gliadin	14-4425-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Re215, Pigeon feathers	14-5032-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rk201, Allergen component nCar p 1 Papain, Papaya	14-5130-10	FDA UDI	Class I	Active
ImmunoCAP Ro212, Streptavidin	14-5320-10	FDA UDI	Class I	Active
EliA RF Positive Control 100	83-0008-31	FDA UDI	Class I	Active
EliA IgA Curve Control	83-0002-71	FDA UDI	Class II	Active
ImmunoCAP Gliadin IgG Control High	34-2332-61	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST	14-5301-10	FDA UDI	Class I	Active
ImmunoCAP Allergen k83, Cotton seed	14-4366-10	FDA UDI	Class I	Active
ImmunoCAP Allergen w1, Common ragweed	14-4162-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf274, Marjoram	14-5084-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf258, Squid	14-5142-10	FDA UDI	Class I	Active

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