FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.0

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Filmarray Gastrointestinal (gi) Panel For Use With The Filmarray 2.0.

Pre-market Notification Details

Device IDK143005
510k NumberK143005
Device Name:FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.0
ClassificationGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Applicant BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
ContactKristen Kanack
CorrespondentKristen Kanack
BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City,  UT  84108
Product CodePCH  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-20
Decision Date2015-02-19
Summary:summary

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