ige-allergen Downloads
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For Europe, Hycor has received CE mark for more than 200 plus allergens. These allergens have been tested through direct comparison to a commercially available allergy system using real patient samples for accuracy, precision, consistency and performance. This level of testing is necessary since data is needed for both FDA submission (for the US) and the future IVDR directive (for Europe). ...
The IVD CAPSULE Aeroallergens is the first rapid, single-use in vitro diagnostic test for the quantitative determination of circulating immunoglobulin E (IgE) specific to the allergen components Phl p 1 + Phl p 5 (combined), Der p 1 + Der p 2 (combined), Alt a 1, Fel d 1 and Can f 1 in uncoagulated human capillary blood collected from the patient’s ...