Tag: DAD

Biomarker, Innovation

US FDA grants 510(k) clearance for DiaSorin’s Covid-19 Direct kit

September 14, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted 510(k) clearance for DiaSorin’s Simplexa COVID-19 Direct kit. The Simplexa COVID-19 Direct kit has been designed for detecting the SARS-CoV-2 virus directly from nasopharyngeal or nasal swab samples. It is developed […]