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 varicella-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.