Analyser software IVDs

Intended purpose

Software applications that are in-vitro diagnostic programs incorporated into modules of the BD Kiestra Microbiology Laboratory Automation system and applied to images of plated media following instrument inoculation and incubation. The Software applications, such as and not limited to the Urine Culture Application, may establish or supplement operational functions including the processing of specimens, generation of data, interpretation, storage, display and/or reporting of results obtained from a clinical laboratory specimen. The outcome of which is used as an aid in the diagnosis of infections, such as urinary tract infection in the example given.