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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
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Parasite Test
Open, Classified		 PCHNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Intestinal Worms Test
Open, Classified		 PCHNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Mycotoxin Panel Test
Open, Classified		 PCHNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
GI Microbiome Profile XL
Open, Classified		 PCHNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
GI Microbiome Profile Small
Open, Classified		 PCHNone listed
Sep 30, 2024BioFire Diagnostics, LLC
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Open, Classified		 PCHK140407
K143005 +1
Aug 6, 2024BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI
Open, Classified		 PCHK140407
K143005 +2
Feb 15, 2024BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.
Open, Classified		 PCHK140407
K143005 +2
Jan 10, 2024BioFire Diagnostics, LLC
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Open, Classified		 PCHK140407
K143005 +2
Jun 28, 2023Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Open, Classified		 PCHK140083
Apr 14, 2023BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
Open, Classified		 PCHK140407
K143005
Mar 15, 2023BioFire Diagnostics, LLC
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Open, Classified		 PCHK140407
K143005 +1
Jun 17, 2022Luminex Corporation
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Open, Classified		 PCHNone listed
Aug 3, 2021Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Open, Classified		 PCHK140083
Mar 18, 2021Luminex Corporation
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Open, Classified		 PCHK140083
Aug 8, 2019BioFire Diagnostics, LLC
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Terminated		 PCHK140407
K143005 +1
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max Enteric Viral Panel EU Catalog # 443985
Terminated		 PCHK181427
Jul 17, 2019Becton Dickinson & Co.
Kit EXT Enteric Bacterial Panel; Catalog # 443812
Terminated		 PCHK170308
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963
Terminated		 PCHK140111
Jul 17, 2019Becton Dickinson & Co.
Kit BD Max Enteric Parasite Panel EU; Catalog # 442960
Terminated		 PCHK143648
Mar 6, 2019BioFire Diagnostics, LLC
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multip
Terminated		 PCHK140407
Feb 22, 2019Luminex Molecular Diagnostics
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human s
Open, Classified		 PCHK140377
May 8, 2018Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-B
Terminated		 PCHK142033
Sep 23, 2014Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence marke
Terminated		 PCHK140083

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