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Device Classification Name
mers-cov and common respiratory pathogens multiplex nucleic acid detection system
De Novo Number
DEN170017
Device Name
FilmArray Respiratory Panel 2 plus (RP2plus)
Requester
biofire diagnostics, llc
515 colorow drive
salt lake city, UT 84108
Contact
kristen j. kanack
Regulation Number
866.4001
Classification Product Code
PZF
Date Received
03/16/2017
Decision Date
11/24/2017
Decision
granted (DENG)
Classification Advisory Committee
Pathology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
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