Device typeMicrobial identification mass spectrometry system IVD: An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.
FDA categorySystem, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Device ID04251204326311
Catalog number1890232
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information