allergen-specific 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). ...
SPECIALfinder Assays are Real-Time PCR kits developed and validated according to UNI-EN 15634-1: 2009 guidelines detecting allergens DNA with high specificity and sensitivity. Absence of cross-reactivity was tested towards a large number of food ingredients to avoid false positive. Combining SPECIALfinder Assays to ION-FORCE DNA Extractor – the DNA ...