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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 device to detect and identify selected microbial agents that cause acute febrile illness
De Novo Number DEN200043
Device Name FilmArray Global Fever Panel
Requester
biofire defense, llc
79 west 4500 south
suite 14
salt lake city,  UT  84107
Contact cynthia phillips
Regulation Number866.3966
Classification Product Code
QMV  
Date Received06/26/2020
Decision Date 11/20/2020
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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