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Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
FDA product code PCH · Class 2 · Microbiology
39
Registered devices
267
Adverse events
24
Recalls
38
510(k) clearances
Devices with this code
Enteric Pathogens (EP) Amplification Tray — LUMINEX CORPORATIONEnteric Pathogens (EP) Extraction Tray — LUMINEX CORPORATIONQIAstat-Dx® GI Panel 2 Mini B — QIAGEN GmbHBIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid — BIOFIRE DIAGNOSTICS, LLCBD MAX™ Enteric Bacterial Panel (US/CAN) — Geneohm Sciences Canada IncFilmArray® Gastrointestinal (GI) Panel — BIOFIRE DIAGNOSTICS, LLCBD MAX™ Enteric Parasite Panel — BECTON, DICKINSON AND COMPANYBioCode MDx 3000 — APPLIED BIOCODE, INC.EasyScreen™ Gastrointestinal Parasite PCR Positive Control — GENETIC SIGNATURES LIMITEDEnteric Pathogens (EP) Extraction Tray — NANOSPHERE, INC.Enteric Pathogens (EP) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONGastrointestinal Pathogen Panel (GPP) Kit — APPLIED BIOCODE, INC.BD MAX™ Enteric Bacterial Panel — BECTON, DICKINSON AND COMPANYPanther Fusion® — Hologic, Inc.BD Enteric Bacterial Panel plus for BD COR™ System — BECTON, DICKINSON AND COMPANYBIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid — BIOFIRE DIAGNOSTICS, LLCEnteric Pathogens (EP) Nucleic Acid Test Cartridge — NANOSPHERE, INC.QIAstat-Dx® Gastrointestinal Panel 2 — QIAGEN GmbHEnteric Pathogens (EP) Stool Sample Preparation Kit — NANOSPHERE, INC.Shiga Toxin Direct Test — GREAT BASIN SCIENTIFIC, INC.Enteric Pathogens (EP) Stool Sample Preparation Kit — LUMINEX CORPORATIONBD Intelliport System — BECTON, DICKINSON AND COMPANYBD Pre-warm Heater — BECTON, DICKINSON AND COMPANYFilmArray® Gastrointestinal (GI) Panel — BIOFIRE DIAGNOSTICS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-05-16 | BioFire Diagnostics, LLC | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| 2024-01-26 | BioFire Diagnostics, LLC | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| 2023-11-27 | BioFire Diagnostics, LLC | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to i |
| 2023-06-05 | Luminex Corporation | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Par |
| 2023-04-25 | BioFire Diagnostics, LLC | The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) P |
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