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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 Number
866.3981
Classification Product Code
QOF
Date Received
05/19/2020
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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