Biocode Gastrointestinal Pathogen Panel (GPP)

Biocode Gastrointestinal Pathogen Panel (GPP) is an FDA 510(k)-cleared medical device (K190585) 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 June 4, 2019. Regulation: 8.