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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name meningitis/encephalitis pathogen multiplex nucleic acid detection system
De Novo Number DEN150013
Device Name FilmArray Meningitis/Encephalitis(ME) Panel
BioFire Diagnostics, LLC
390 wakara way
salt lake city,  UT  84108
Contact kristen j kanack
Regulation Number866.3970
Classification Product Code
Date Received04/09/2015
Decision Date 10/08/2015
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct