IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay granted EUA from FDA

IMDx announced today that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test, which is authorized for use on multiple instrument platforms (the Applied Biosystems 7500, the 7500 FAST Real-Time PCR Systems, and the 7500 Fast Dx Real-Time PCR Instrument) by CLIA High Complexity Laboratories to detect and differentiate 2009 Influenza A H1N1, uses a single test format and produces results in ninety minutes.  "By receiving authorization for use on multiple instrument platforms, IMDx is able to provide a rapid assay solution that is flexible and adaptable to the wider needs of molecular diagnostics laboratory customers," said Alice Jacobs, M.D., IMDx, Chairman & CEO.

SOURCE IntelligentMDx

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