Product code

AI devices with FDA product code PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Product code PEX (“System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Microbiology panel (2). The most recent decision was MALDI BIOTYPER CA (MBT-CA) SYSTEM on November 21, 2013.

2AI devices
2Companies
2013First decision
2013-11-21Latest decision

Trend: devices per year

2013: 2
2013
AI devices with FDA product code PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates per year: 2013 2

All 2 devices, newest first