Interpretive software IVDs

Intended purpose

The intended purpose of the Bruker IVD MALDI Biotyper application (referred to as "IVDMALDI Biotyper") is the calculation of the similarity of a mass spectrometry-based pattern profile of an unknown microorganism to mass spectrometry- based pattern profiles of characterized strains stored in a reference library. This allows identification of unknown microorganisms (bacteria, yeasts and fungi) at the species level after standardized sample preparation procedures, and detection of enzyme activity related to antibiotic resistance mechanisms.