Device Debut: Curetis' Unyvero Infectious Disease Tester Earns De Novo Clearance
Executive Summary
FDA granted de novo clearance to Curetis' Unyvero "sample-to-answer" diagnostic system and the Lower Respiratory Tract Infection Application Cartridge, the company announced April 3. Unyvero works with the Unyvero LRT Application Cartridge to provides rapid infectious disease testing directly from aspirate samples in less than five hours. The FDA decision comes a day after the Singapore Health Sciences Authority approved Curetis' Unyvero BCU Cartridge.
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