FDA Clearance of PrimeraDx ICEPlex, C. Diff Assay Opens Doors for Additional Tests | GenomeWeb

PrimeraDx said this week that the US Food and Drug Administration has granted 510(k) clearance for its ICEPlex C. difficile assay kit and ICEPlex molecular diagnostics system.

The approval provides PrimeraDx with a runway from which to commercially launch a number of additional multi-analyte in vitro diagnostics in infectious disease and oncology, including companion diagnostics.

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