Home » DiaSorin Gains FDA Clearance for VZV Swab Assay
DiaSorin Gains FDA Clearance for VZV Swab Assay
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.
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