BioFire Respiratory Panel 2.1 (RP2.1)

Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

Biofire Diagnostics, LLC

The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Biofire Respiratory Panel 2.1 (rp2.1).

Pre-market Notification Details

DeNovo IDDEN200031
Device Name:BioFire Respiratory Panel 2.1 (RP2.1)
ClassificationMulti-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Applicant Biofire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKristen J Kanack
Product CodeQOF  
CFR Regulation Number866.3981 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2020-05-19
Decision Date2021-03-17
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020529 DEN200031 000

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