FDA Grants Second Authorization for Focus Diagnostics' H1N1 Flu Test | GenomeWeb

NEW YORK (GenomeWeb News) – Clinical lab firm Quest Diagnostics said Friday that the US Food and Drug Administration has issued a second emergency use authorization for a 2009 H1N1 flu test made by its Focus Diagnostics subsidiary.

Quest said that the new EUA allows Focus to market and offer its Simplexa Influenza A H1N1 (2009) test for use on 3M's Integrated Cycler to CLIA high-complexity laboratories for the duration of the emergency period. 3M's system is a microfluidic molecular diagnostic testing system that is not yet cleared by the FDA.

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