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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 w 4500 s
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
Predetermined Change
Control Plan Authorized		 No
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