FilmArray Meningitis/Encephalitis(ME) Panel

Meningitis/encephalitis Pathogen 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 Meningitis/encephalitis(me) Panel.

Pre-market Notification Details

DeNovo IDDEN150013
Device Name:FilmArray Meningitis/Encephalitis(ME) Panel
ClassificationMeningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Applicant BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
ContactKristen J Kanack
Product CodePLO  
CFR Regulation Number866.3970 [🔎]
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 Received2015-04-09
Decision Date2015-10-08
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020130 DEN150013 000
00815381020123 DEN150013 000

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