PCH

Product Code: PCH


Products Classified as PCH

3555Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay SystemGastrointestinal Microorganism Multiplex Nucleic Acid-based Assay.

Total Product Life Cycle (TPLC) Devices

3555Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay SystemGastrointestinal Microorganism Multiplex Nucleic Acid-based Assay.

Pre-market Notifications for PCH

K220607BD MAX Enteric Viral PanelBecton, Dickinson And Company
K220193BD MAX Enteric Parasite PanelBecton, Dickinson And Company
K191161XTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.
K191160XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.
K190585Biocode Gastrointestinal Pathogen Panel (GPP)Applied Biocode, Inc.
K183023XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.
K183030XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.
K182703EntericBio Dx AssaySerosep, Ltd.
K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson And Company
K180041BioCode Gastrointestinal Pathogen Panel (GPP)Applied Biocode, Inc.
K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBECTON, DICKINSON AND COMPANY
K160459FilmArray Gastrointestinal Panel (GI) For Use With FilmArray TorchBIOFIRE DIAGNOSTICS, LLC
K152955Great Basin Shiga Toxin Direct TestGREAT BASIN SCIENTIFIC, INC.
K143648BD MAX Enteric Parasite Panel, BD MAX InstrumentBECTON, DICKINSON AND COMPANY
K143005FilmArray Gastrointestinal (GI) Panel For Use With The FilmArray 2.0BioFire Diagnostics, LLC

Global Unique Device Identification Database

00382904438128Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00382904433802Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00382904433789Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00382904429638Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00382904429607Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00815381020116Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
00815381020109Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
07332940000974Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
00840487100493Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00857573006065Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00857573006089Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00857573006041Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
00382905168000Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
04053228043249Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
09351179004070Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Maude Adverse Events

BIOFIRE GI PANELBIOFIRE DIAGNOSTICS, INC.2019-09-12
BIOFIRE GI PANELBIOFIRE DIAGNOSTICS, LLC2019-09-12
BIOFIRE GI PANELBIOFIRE DIAGNOSTICS, LLC2019-09-12
BIOFIRE GI PANELBIOFIRE DIAGNOSTICS, LLC2019-09-12
FILMARRAY? GASTROINTESTINAL (GI) PANELBIOFIRE DIAGNOSTICS, LLC2019-07-11
BIOFIRE FILMARRAY GASTROINTESTINAL PANELBIOFIRE DIAGNOSTICS LLC2019-02-26
XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)LUMINEX MOLECULAR DIAGNOSTICS2014-03-06
XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)LUMINEX MOLECULAR DIAGNOSTICS2014-03-06
XTAG GASTROINTESTINAL PATHOGEN PANEL (XTAG GPP)LUMINEX MOLECULAR DIAGNOSTICS2014-03-06
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.