FDA Grants Emergency Use Authorization for IMDx H1N1 Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted emergency use authorization for IntelligentMDx's (IMDx) test for the 2009 H1N1 flu virus, the Cambridge, Mass.-based company said today.

The emergency use authorization does not clear the company's Influenza A H1N1 Real-Time RT-PCR Assay for use beyond the period of the 2009 H1N1 influenza public health emergency, which is currently scheduled to expire on April 26, 2010, unless it is renewed or terminated sooner.

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