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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 multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
De Novo Number DEN200031
Device Name BioFire Respiratory Panel 2.1 (RP2.1)
Requester
biofire diagnostics, llc
515 colorow drive
salt lake city,  UT  84108
Contact kristen j kanack
Regulation Number866.3981
Classification Product Code
QOF  
Date Received05/19/2020
Decision Date 03/17/2021
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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