Qiagen Gets FDA 510(k) Clearance for MDx System, C. Diff Assay | GenomeWeb

NEW YORK (GenomeWeb) — Qiagen has received 510(k) clearance from the US Food and Drug Administration for its QIAsymphony RGQ MDx system and Artus C. difficile QS-RGQ MDx kit, the company said Monday after the close of the market.

QIAsymphony RGQ MDx is a modular system for performing entire laboratory workflows. It comprises the QIASymphony SP for sample preparation, QIAsymphony AS for assay setup, and Rotor-Gene Q MDx real-time PCR detection system, which received FDA clearance in 2012.

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