FDA Product Code QBN: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
The Maldi Biotyper Ca System Is A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ionization - Time Of Flight (maldi-tof) For The Identification And Differentiation Of Microorganisms Cultured From Human Specimens. The Maldi Biotyper Ca System Is A Qualitative In Vitro Diagnostic Device Indicated For Use In Conjunction With Other Clinical And Laboratory Findings To Aid In The Diagnosis Of Bacterial And Fungal Infections.
Leading manufacturers include bioMerieux, Inc..
List of Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates devices (product code QBN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →