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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 Number
866.3966
Classification Product Code
QMV
Date Received
06/26/2020
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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