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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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De Novo Number DEN160048
Device Name FilmArray NGDS Warrior Panel
Requester
biofire defense, llc
79 west 4500 south, suite 14
salt lake city,  UT  84107
Contact cynthia phillips
Classification Product Code
PRD
Date Received10/17/2016
Decision Date 02/14/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
Type Direct
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