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Device Debut: Curetis' Unyvero Infectious Disease Tester Earns De Novo Clearance

 
• By Reed Miller

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.

Approved stamp
• Source: shutterstock.com

Curetis announced two important approvals this week. The Germany company's Unyvero System and Lower Respiratory Tract Infection Application Cartridge earned de novo clearance from the US FDA on April 3. On April 4, the Singapore Health Sciences Authority's approved Curetis' Unyvero BCU Cartridge for bloodstream infections.

Curetis filed for the de novo clearance in January 2017, hoping to install 200 systems worldwide by the end of 2017. The company's worldwide installed base at the end of 2017 totaled 175 analyzers

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More from Policy & Regulation

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