Qiagen scores regulatory win for 2 diagnostic devices

04/18/2012 | GenomeWeb Daily News (free registration)

The FDA has granted Qiagen 510(k) clearance for Rotor-Gene Q MDx, an automated molecular diagnostic platform tailored for in vitro diagnostic use by clinical laboratories in running nucleic acid tests approved in the U.S. The agency also cleared Qiagen's artus Infl A/B RG RT-PCR kit, an IVD molecular diagnostic assay designed to spot and distinguish the A and B strains of influenza in real time.

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