FilmArray Respiratory Panel 2 Plus (RP2plus)

Mers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

BioFire Diagnostics, LLC

The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Filmarray Respiratory Panel 2 Plus (rp2plus).

Pre-market Notification Details

DeNovo IDDEN170017
Device Name:FilmArray Respiratory Panel 2 Plus (RP2plus)
ClassificationMers-cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKristen J. Kanack
Product CodePZF  
CFR Regulation Number866.4001 [🔎]
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 AdvisoryPathology
TypeDirect
Date Received2017-03-16
Decision Date2017-11-24
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020307 DEN170017 000
00815381020291 DEN170017 000

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