Great Basin Files 510(k) for C. difficile MDx | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Great Basin today announced it has filed for 510(k) clearance of its molecular diagnostic test for Clostridium difficile.

In addition to its application to the US Food and Drug Administration, the Salt Lake City firm said also that it plans to submit an application to the European Union by the end of the year to obtain CE marking for the test, and upon regulatory approvals in the US and Europe, the company will launch its assay and instrument immediately.

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