PEX

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Product code

PEX

Device name

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Device class

Class 2

21 CFR

21 CFR 866.3361

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

Definition text from the FDA device classification database (U.S. federal government work, public domain).