EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel

Gram-negative Bacteria And Associated Resistance Markers

GenMark Diagnostics, Incorporated

The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Blood Culture Identification Gram Negative (bcid-gn) Panel.

Pre-market Notification Details

Device IDK213236
510k NumberK213236
Device Name:EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel
ClassificationGram-negative Bacteria And Associated Resistance Markers
Applicant GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad,  CA  92008
ContactAlan Maderazo
CorrespondentAlan Maderazo
GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad,  CA  92008
Product CodePEN  
Subsequent Product CodePAM
Subsequent Product CodePEO
CFR Regulation Number866.3365 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-30
Decision Date2022-04-27

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