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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 orthopedic infection microbial multiplex nucleic acid detection system
De Novo Number DEN200066
Device Name BioFire Joint Infection (JI) Panel
Requester
biofire diagnostics, llc
515 colorow drive
salt lake city,  UT  84108
Contact kevin bourzac
Regulation Number866.3988
Classification Product Code
QSN  
Date Received10/27/2020
Decision Date 04/29/2022
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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