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 Luminex Molecular Diagnostics, Inc., Biofire Diagnostics, LLC and Becton, Dickinson and Company.