FDA Product Code PCH: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
FDA product code PCH covers gastrointestinal pathogen panel multiplex nucleic acid tests.
These assays simultaneously detect and identify multiple bacterial, viral, and parasitic pathogens responsible for infectious diarrhea — including Salmonella, Campylobacter, norovirus, Cryptosporidium, and others — from a single stool sample. Multiplex panels replace sequential single-target tests with a single comprehensive result.
PCH devices are Class II medical devices, regulated under 21 CFR 866.3990 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Biofire Diagnostics, LLC, Becton, Dickinson and Company and Cepheid.
List of Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System devices (product code PCH). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →