Qiagen NV, a leading global provider of sample & assay technologies, has received the two US Food and Drug Administration (FDA) 510(k) clearances for its real-time PCR (polymerase chain reaction) instrument Rotor-Gene Q MDx and a compatible test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit, for in vitro diagnostic use (IVD).
“The FDA clearances for the Rotor-Gene Q MDx along with the first assay for use on this system represent an important milestone for Qiagen,” said Peer M Schatz, chief executive officer of Qiagen NV. “The various Rotor-Gene Q models marketed by Qiagen are not only an integral part of our revolutionary lab automation platform QIAsymphony RGQ, but are also among the most widely used stand-alone molecular detection platforms worldwide. Outside the US, our customers already have access to a broad portfolio of molecular diagnostic tests for use on these platforms. The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the US as well.”