FDA clears Simplexa COVID-19, flu A/B, RSV Direct kit
December 2025—Diasorin has received FDA 510(k) clearance for the Simplexa COVID-19/Flu A/B and RSV Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, influenza A and B virus, and respiratory syncytial virus directly from nasopharyngeal and nasal swab specimens. The kit runs on the Liaison MDX system and provides differential detection in about 45 minutes.