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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 mers-cov and common respiratory pathogens multiplex nucleic acid detection system
De Novo Number DEN170017
Device Name FilmArray Respiratory Panel 2 plus (RP2plus)
BioFire Diagnostics, LLC
515 colorow drive
salt lake city,  UT  84108
Contact kristen j. kanack
Regulation Number866.4001
Classification Product Code
Date Received03/16/2017
Decision Date 11/24/2017
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct