AI devices with FDA product code PRE — Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Product code PRE (“Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Microbiology panel (1). The most recent decision was TriVerity on January 10, 2025.