FilmArray Global Fever Panel

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

BioFire Defense, LLC

The following data is part of a De Novo classification by Biofire Defense, Llc with the FDA for Filmarray Global Fever Panel.

Pre-market Notification Details

DeNovo IDDEN200043
Device Name:FilmArray Global Fever Panel
ClassificationDevice To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Applicant BioFire Defense, LLC 79 West 4500 South suite 14 Salt Lake City,  UT  84107
ContactCynthia Phillips
Product CodeQMV  
CFR Regulation Number866.3966 [🔎]
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 Received2020-06-26
Decision Date2020-11-20
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851458005242 DEN200043 000

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