Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next - level molecular diagnostic solutions, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration for its Unyvero Platform and the Unyvero LRT Lower Respiratory Tract Cartridge. The submission is for the use of Unyvero for the diagnosis of lower respiratory tract infections. The LRT panel includes up to 36 analytes for all key pathogens and antibiotic resistances in this indication area.