Antimicrobial susceptibility/resistance testing interpretive software IVD

Definition
An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clinical specimen, to determine the susceptibility, intermediate or resistance categorization of the microbial species. It is installed on an off-the-shelf computer or a web-based platform, and compares assay results (e.g., an acquired image, mass spectrum) to reference data to determine antimicrobial resistance (e.g., beta-lactamase, carbapenamase, and/or cephalosporinase activity). Results are used to guide patient treatment options.
GUDID devices
1
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07350136800344ASTar BC G- Kit softwareQ-Linea AB50005827 version 22026-05-12