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Panels › Microbiology › Product code PEN · Class 2

Gram-Negative Bacteria And Associated Resistance Markers

Regulation 866.3365

1510(k)s in 12 months (12 all time)
0recalls in 12 months (20 all time)
20recalls that name a 510(k)
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Top companies in PEN

Company510(k)sRecalls
Biofire Diagnostics, Inc.613
Nanosphere, Inc.14
Luminex Corporation13
Genmark Diagnostics, Incorporated20
Icubate, Inc.10
QIAGEN GmbH10
Decided510(k)Device and applicantCode
Sep 24, 2026K262168QIAstat-Dx BCID GN Plus AMR Panel
QIAGEN GmbH, DE
PEN
Apr 18, 2025K243013LIAISON PLEX Gram-Negative Blood Culture Assay
Luminex Corporation
PEN
Dec 20, 2024K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
Biofire Diagnostics, LLC
PEN
Apr 27, 2022K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Genmark Diagnostics, Incorporated
PEN
Mar 18, 2020K193519BioFire Blood Culture Identification 2 (BCID2) Panel
Biofire Diagnostics, LLC
PEN
Jun 28, 2019K190341iC-GN iC-Cassette for use on the iC-System
Icubate, Inc.
PEN
Apr 12, 2019K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
Genmark Diagnostics, Incorporated
PEN
Jul 5, 2018K181493FilmArray Blood Culture Identification (BCID) Panel
Biofire Diagnostics, LLC
PEN
Mar 15, 2016K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
Biofire Diagnostics, LLC
PEN
Jan 30, 2015K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
Biofire Diagnostics, LLC
PEN
Jan 8, 2014K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
Nanosphere, Inc.
PEN
Jun 21, 2013K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
Biofire Diagnostics, Inc.
PEN

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