FDAnews
www.fdanews.com/articles/195235-diasorin-gains-fda-clearance-for-vzv-swab-assay

DiaSorin Gains FDA Clearance for VZV Swab Assay

December 19, 2019

The FDA granted clearance for DiaSorin’s Simplexa VZV Swab Direct assay for detection of ┬ávaricella-zoster virus from cutaneous and mucocutaneous swab samples.

The assay is designed for use on the company’s Liaison MDX system, a thermocycler that can accommodate both sample-to-answer testing and higher volume testing.

The company received the FDA’s clearance for the Simplexa VZV Direct assay in June, which uses cerebrospinal fluid samples.

View today's stories