Archive: Company News
Company News: Curetis Files for U.S. FDA Clearance for Unyvero Platform and LRT Application Cartridge
– Final panel demonstrates overall weighted average sensitivity of 91.4% and overall weighted average specificity of 99.5% across all lower respiratory tract panel pathogens
– Unyvero results available after approximately five hours only, compared to three to four days on average for microbiology culture based methods
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.