QIAGEN receives FDA approval of artus CMV RGQ MDx kit QIAGEN N.V. announced that its artus CMV RGQ MDx Kit for human cytomegalovirus, or CMV, has been approved by the FDA under a full premarket approval, or PMA. The test is the only FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests. artus CMV RGQ MDx runs on QIAGEN's Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony modular family of automated instruments.
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