BioCode Gastrointestinal Pathogen Panel (GPP)

BioCode Gastrointestinal Pathogen Panel (GPP) is an FDA 510(k)-cleared medical device (K242877) manufactured by Applied BioCode, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2025. Regulation: 8.