DeviceClearance

Product code PEX— Microbiology

VITEK MS

Classification name
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Device class
Class 2
Regulation
21 CFR 866.3361
Advisory panel
Microbiology
Total cleared
5
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PEX under 21 CFR 866.3361, via openFDA

Market context for product code PEX

FDA has cleared 5 devices under product code PEX between 2013 and 2017, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEX

Recent clearances under product code PEX

Data sourced from openFDA. This site is unofficial and independent of the FDA.