Prodesse Files for FDA OK for C. Difficile Assay | GenomeWeb

NEW YORK (GenomeWeb News) – Prodesse today said that it had filed for US Food and Drug Administration clearance of its molecular diagnostics assay for Clostridium difficle.

The Milwaukee, Wis.-based firm said that it had filed for 510(k) clearance of the ProGastro Cd Assay following clinical trials conducted at several clinical labs in the US. The assay is already being used for clinical diagnostics in Europe, and additional studies of the test are currently being conducted in the UK.

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