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Panels › Microbiology › Product code PCH · Class 2

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Regulation 866.3990

3510(k)s in 12 months (38 all time)
5recalls in 12 months (24 all time)
18recalls that name a 510(k)
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Top companies in PCH

Company510(k)sRecalls
Biofire Diagnostics68
Luminex Molecular Diagnostics, Inc.81
Luminex Corporation15
Becton, Dickinson and Company50
GET TESTED INTERNATIONAL AB05
QIAGEN GmbH50
Becton Dickinson & Co.04
Applied BioCode, Inc.30
Cepheid20
Hologic20
Decided510(k)Device and applicantCode
May 19, 2026K253722LIAISON PLEX Gastrointestinal Flex Assay
Luminex Corporation
PCH
Mar 9, 2026K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
QIAGEN GmbH, DE
PCH
Jan 16, 2026K251721Xpert GI Panel
Cepheid
PCH
Oct 22, 2025K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
QIAGEN GmbH, DE
PCH
Sep 25, 2025K251993Panther Fusion GI Expanded Bacterial Assay
Hologic, Inc.
PCH
Sep 25, 2025K251868Panther Fusion GI Bacterial Assay
Hologic
PCH
Feb 28, 2025K250324QIAstat-Dx GI Panel 2 Mini B
QIAGEN GmbH, DE
PCH
Jan 16, 2025K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
Biofire Diagnostics, LLC
PCH
Jan 10, 2025K242877BioCode Gastrointestinal Pathogen Panel (GPP)
Applied BioCode, Inc.
PCH
Jan 8, 2025K243813QIAstat-Dx GI Panel 2 Mini B&V
QIAGEN GmbH, DE
PCH
Nov 7, 2024K242367BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Biofire Diagnostics, LLC
PCH
May 31, 2024K220062QIAstat-Dx Gastrointestinal Panel 2
QIAGEN GmbH, DE
PCH
May 29, 2024K232672EasyScreen Gastrointestinal Parasite Detection Kit
Genetic Signatures Limited, AU
PCH
Mar 16, 2023K230404BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Biofire Diagnostics, LLC
PCH
Sep 21, 2022K220607BD MAX Enteric Viral Panel
Becton, Dickinson and Company
PCH
Aug 19, 2022K220193BD MAX Enteric Parasite Panel
Becton, Dickinson and Company
PCH
Nov 12, 2019K191161xTAG Gastrointestinal Pathogen Panel (GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Nov 4, 2019K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Jun 19, 2019K182703EntericBio Dx Assay
Serosep , Ltd., IE
PCH
Jun 5, 2019K190585Biocode Gastrointestinal Pathogen Panel (GPP)
Applied BioCode, Inc.
PCH
Nov 30, 2018K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Nov 30, 2018K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Nov 29, 2018K181427BD MAX Enteric Viral Panel, BD MAX Instrument
Becton, Dickinson and Company
PCH
Sep 28, 2018K180041BioCode Gastrointestinal Pathogen Panel (GPP)
Applied BioCode, Inc.
PCH
May 2, 2017K170308BD MAX Extended Enteric Bacterial Panel, BD MAX System
Becton, Dickinson and Company
PCH
Apr 1, 2016K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
Biofire Diagnostics, LLC
PCH
Mar 22, 2016K152955Great Basin Shiga Toxin Direct Test
Great Basin Scientific, Inc.
PCH
Aug 25, 2015K143648BD MAX Enteric Parasite Panel, BD MAX Instrument
Becton, Dickinson and Company
PCH
Feb 19, 2015K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
Biofire Diagnostics, LLC
PCH
Nov 26, 2014K142501Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s
Cepheid
PCH
Oct 24, 2014K140647XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Oct 10, 2014K142033VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
Nanospere,Inc.
PCH
Sep 16, 2014K140377XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)
Luminex Molecular Diagnostics, Inc., CA
PCH
Jun 20, 2014K140083VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
Nanosphere, Inc.
PCH
May 2, 2014K140407FILMARRAY GASTROINTESTINAL (GI) PANEL
Biofire Diagnostics
PCH
Mar 21, 2013K121894XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
Luminex Molecular Diagnostics, Inc., CA
PCH
Jan 16, 2013K123274PROGASTRO SSCS ASSAY
Gen-Probe Prodesse, Inc.
PCH
Jan 14, 2013DEN130003XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)
Luminex Molecular Diagnostics, Inc., CA
PCH

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