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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » DiaSorin Molecular Gets CE Mark for VZV Swab Direct Molecular Test

DiaSorin Molecular Gets CE Mark for VZV Swab Direct Molecular Test

Sep 25, 2019
|
staff reporter

NEW YORK – DiaSorin Molecular has received CE mark for an assay that detects DNA of varicella-zoster virus (VZV) directly from swab specimens, the firm announced today.

The test, called the Simplexa VZV Swab Direct assay, has also been submitted to the US Food and Drug Administration for 510(k) clearance, the firm said in a statement.

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