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Noveos allergy testing instrument cleared

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March 2019—Hycor Biomedical received FDA 510(k) clearance for its new allergy testing system, Noveos. Features of the system include a reduction in sample size (4 μL of serum per test), reduced blood-based interferences, less variability within allergen lots, increased accuracy, and improved walkaway time, the company reports.

Hycor also received clearance for the system’s first specific IgE assay to detect dust mite allergen and is focused on developing additional assays.

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