In vitro diagnostic company Hycor Biomedical disclosed on Wednesday that it has passed the US Food and Drug Administration's (FDA) 510(k) clearance for its new allergy testing system, NOVEOS.
NOVEOS, which employs microparticles, chemiluminescence and liquid ready-to-use reagent, provides the first-of-its-kind technology for routine allergy testing labs in over 20 years, added the company.
According to the company, NOVEOS addresses the common issues the laboratorians face with current technologies and now offers a significant reduction in sample size, reduced blood-based interferences, less variability within allergen lots, increased accuracy as well as improved walk-away time for laboratory technicians.
Additionally, the company received simultaneous clearance for the NOVEOS' first Specific IgE (sIgE) assay to detect Dust Mite allergen (D001) and is focused on the development of additional assays to provide a comprehensive menu to customers. NOVEOS product line recently received CE mark in the EU.
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