Securing FDA Clearance for Rotor-Gene Instrument and Flu Assay, Qiagen Looks to Expand IVD Test Menu | GenomeWeb

By Bernadette Toner

Qiagen this week announced that it has received 510(k) clearance from the US Food and Drug Administration for its Rotor-Gene Q MDx real-time PCR instrument and a compatible test for influenza A/B, the Artus Infl A/B RG RT-PCR kit.

The approval allows the firm to sell the instrument and the assay for in vitro diagnostic use in the US market and lays the groundwork for it to expand its IVD test menu for the system.

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