Device Dossier

Analyser software IVDs

Device Dossier for Analyser software IVDs (CT1250 - Analyser software IVDs, Class 3, sponsor Carl Zeiss). ARTG record, intended purpose, GMDN category —…

Intended purpose

Intended to be used for karyotyping with real time microscope images from cultured and stained cell specimens in their metaphase. The operator is able to document the resulting images in both hardcopy and electronically archiving them for later review. The colour fluorescence (Isis) mode allows fast and easy acquisition, processing, archiving, and documentation of fluorescent microscopic images.

TGA Public Summary