BioFire Blood Culture Identification 2 (BCID2) Panel

Gram-negative Bacteria And Associated Resistance Markers

BioFire Diagnostics, LLC

The following data is part of a premarket notification filed by Biofire Diagnostics, Llc with the FDA for Biofire Blood Culture Identification 2 (bcid2) Panel.

Pre-market Notification Details

Device IDK193519
510k NumberK193519
Device Name:BioFire Blood Culture Identification 2 (BCID2) Panel
ClassificationGram-negative Bacteria And Associated Resistance Markers
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKristen Kanack
CorrespondentKristen Kanack
BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
Product CodePEN  
Subsequent Product CodePAM
Subsequent Product CodePEO
CFR Regulation Number866.3365 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
510k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-03-18

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