Device typeCell morphology analyser IVD, automated/semi-automated: An electrically-powered automated or semi-automated laboratory instrument intended to be used to capture digital images of a clinical specimen at the microscopic level in order to view, count, record and evaluate the morphological characteristics of the cells and other biological components. It is a computerized optical unit consisting of a microscope, camera and software.
FDA categoryAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
Device ID08426950643708
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information