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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 3 of 6

Device	Model / Reference	Registries	Class	Status
ImmunoCAP Allergen Rt206, Chestnut	14-5140-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx72, Spices	14-4359-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf369, Catfish	14-4930-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rm220, Allergen component rAsp f 3 Aspergillus fumigatus	14-5295-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf278, Bay leaf	14-5049-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rrx2, Regional	14-5184-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx23, Food	14-4855-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf381, Red snapper	14-4931-10	FDA UDI	Class I	Active
Maintenance Solution Kit Large	10-9537-01	FDA UDI	Class I	Active
ImmunoCAP Tryptase Conjugate 50	34-2314-22	FDA UDI	Class II	Active
ImmunoCAP Allergen Rt44, Hackberry	14-4943-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgA Curve Controls	10-9308-01	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rt207, Douglas fir	14-5146-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf293, Papaya	14-5089-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf270, Ginger	14-5072-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Re204, Allergen component nBos d 6 BSA, Cow	14-5009-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re217, Ferret epithelium	14-5157-10	FDA UDI	Class I	Active
EliA dsDNA Positive Control 250	83-0045-21	FDA UDI	Class I	Active
ImmunoCAP Allergen tx2, Tree pollen	14-4270-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf265, Caraway	14-5057-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf328, Fig	14-5244-10	FDA UDI	Class I	Active
EliA M2 Positive Control 100	83-0014-81	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Re214, Finch feathers	14-5013-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf288, Blueberry	14-5052-10	FDA UDI	Class I	Active
EliA IgA Conjugate	83-0002-81	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf412, Orange roughy	14-4935-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rrx3, Regional	14-5198-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf317, Coriander	14-5214-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen f266, Mace	14-5083-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rt55, Scotch broom	14-4946-10	FDA UDI	Class I	Active
EliA IgG Calibrators	83-1000-01	FDA UDI	Class II	Active
ImmunoCAP Rare Allergen Rf296, Carob	14-5137-10	FDA UDI	Class I	Active
ImmunoCAP Specific IgE Curve Controls	10-9408-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf312, Swordfish	14-5205-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf313, Anchovy	14-5209-10	FDA UDI	Class I	Active
ImmunoCAP Allergen fx8, Food	14-4845-01	FDA UDI	Class II	Active
ImmunoCAP Allergen Rw203, Rape	14-5024-10	FDA UDI	Class I	Active
ImmunoCAP Rare Allergen Rf344, Sage	14-5281-10	FDA UDI	Class I	Active
EliA ANCA/GBM Positive Control 100	83-0007-01	FDA UDI	Class I	Active
ImmunoCAP Allergen Re218, Chicken droppings	14-5229-10	FDA UDI	Class I	Active
ImmunoCAP IgE/ECP/Tryptase Sample Diluent	34-2264-51	FDA UDI	Class II	Active
ImmunoCAP Allergen Rf307, Hake	14-5194-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf222, Tea	14-5104-10	FDA UDI	Class I	Active
ImmunoCAP Allergen d202, Allergen component nDer p 1, House dust mite	14-4966-01	FDA UDI	Class II	Active
EliA ANA Positive Control 100	83-0006-91	FDA UDI	Class I	Active
ImmunoCAP Specific IgG Conjugate	34-2294-41	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf182, Lima bean	14-4929-10	FDA UDI	Class I	Active
ImmunoCAP Allergen c202, Suxamethonium (Succinylcholine)	14-5266-10	FDA UDI	Class I	Active
ImmunoCAP Allergen Rf221, Coffee	14-5065-10	FDA UDI	Class I	Active
ImmunoCAP Allergen f335, Lupine seed	14-5254-10	FDA UDI	Class I	Active

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