ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). An in vitro diagnostic medical device (IVD)ORTHO VISION Analyser for ORTHO BioVue Cassettes Software Versions: 2.12.6 and below Product Code: 6904579ORTHO VISION Max Analyser for ORTHO BioVue CassettesSoftware Versions: 2.12.10Product Code: 6904578ARTG Number: 229946