NEW YORK (GenomeWeb) – DiaSorin announced on Tuesday that the US Food and Drug Administration has provided 510(k) clearance of the firm's Simplexa C. difficile Direct Assay for marketing in the US.

The assay has been available outside the US since November and runs on DiaSorin's Liaison MDX benchtop instrument, which provides clinically validated, real-time PCR results, the Italian in vitro diagnostic firm said in a statement.

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