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FDA Authorizes First Test for Candida Auris
Devices Submissions and Approvals
The FDA authorized the first test for identifying Candida auris, a multidrug resistant pathogen that can cause serious infections in hospitalized patients.
The agency approved a new use of the Bruker Maldi Biotyper CA system for identifying the pathogen, expanding the system’s uses to 424 clinically relevant bacteria and yeast species.
The system uses mass spectrometry in combination with a reference organism database.