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Device Classification Name
meningitis/encephalitis pathogen multiplex nucleic acid detection system
De Novo Number
DEN150013
Device Name
FilmArray Meningitis/Encephalitis(ME) Panel
Requester
biofire diagnostics, llc
390 wakara way
salt lake city, UT 84108
Contact
kristen j kanack
Regulation Number
866.3970
Classification Product Code
PLO
Date Received
04/09/2015
Decision Date
10/08/2015
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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