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Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
FDA product code PCH · Class 2 · Microbiology
38
Registered devices
256
Adverse events
24
Recalls
38
510(k) clearances
Devices with this code
FilmArray® Gastrointestinal (GI) Panel — BIOFIRE DIAGNOSTICS, LLCEnteric Bacterial Panel Diluent for BD COR™ System — BECTON, DICKINSON AND COMPANYBD MAX™ Enteric Parasite Panel — BECTON, DICKINSON AND COMPANYStool Bacterial Pathogens Panel — GREAT BASIN SCIENTIFIC, INC.FilmArray® Gastrointestinal (GI) Panel — BIOFIRE DIAGNOSTICS, LLCPanther Fusion® — Hologic, Inc.Enteric Pathogens (EP) Nucleic Acid Test Cartridge — NANOSPHERE, INC.Panther Fusion® — Hologic, Inc.BD Enteric Bacterial Panel plus for BD COR™ System — BECTON, DICKINSON AND COMPANYEnteric Pathogens (EP) Extraction Tray — LUMINEX CORPORATIONEasyScreen™ Gastrointestinal Parasite PCR Positive Control — GENETIC SIGNATURES LIMITEDxTAG® Gastrointestinal Pathogen Panel (GPP) — Luminex Molecular Diagnostics, IncBD Enteric Bacterial Panel for BD COR™ System — BECTON, DICKINSON AND COMPANYEnteric Pathogens (EP) Amplification Tray — NANOSPHERE, INC.Xpert Norovirus — CEPHEIDQIAstat-Dx® GI Panel 2 Mini B — QIAGEN GmbHXpert — CEPHEIDBIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid — BIOFIRE DIAGNOSTICS, LLCQIAstat-Dx® GI Panel 2 Mini B&V — QIAGEN GmbHEnteric Pathogens (EP) Extraction Tray — NANOSPHERE, INC.Panther Fusion® — Hologic, Inc.BD MAX™ Enteric Bacterial Panel — BECTON, DICKINSON AND COMPANYBD MAX™ Enteric Viral Panel — BECTON, DICKINSON AND COMPANYBD MAX™ Enteric Bacterial Panel (US/CAN) — Geneohm Sciences Canada Inc
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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