Intended Use (US)
The Genetix CytoVision® system is an automated scanning microscope and image analysis system.
In the US, CytoVision Karyotyper and CEP XY are For In-Vitro Diagnostic Use.
CytoVision Karyotyper is a rapid metaphase finder and computer aided chromosome analysis system which assists the cytogeneticist in viewing the chromosome displays and looking for cellular anomalies. The Karyotyper enables the qualified cytogeneticist to rapidly and accurately analyze the chromosome banding pattern. All diagnostic decisions are made by the qualified clinician.
CytoVision CEPXY_ENG is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories. Abbott Park, Illinois, U.S.A) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants. All diagnostic decisions are made by the qualified clinician.
CytoVision Fluorescence In-Situ Hybridization (FISH), Comparative Genomic Hybridization (CGH), SPOT AX, RxFISH Color Chromosome Analysis, and M-FISH - For Research Use Only*. Not for Use in Diagnostic Procedures.
The Flexible Karyotyper System is For Research Use Only*. Not for Use in Diagnostic Procedures
Intended Use (EU and CANADA)
In the EU and Canada, ONLY CytoVision Karyotyper is For In-Vitro Diagnostic Use. All other applications are For Research Use Only*. Not for Use in Diagnostic Procedures.
CytoVision Fluorescence In-Situ Hybridization (FISH), Comparative Genomic Hybridization (CGH), SPOT AX, RxFISH Color Chromosome Analysis, and M-FISH - For Research Use Only*. Not for Use in Diagnostic Procedures.
The Flexible Karyotyper System is For Research Use Only*. Not for Use in Diagnostic Procedures
Note* : A Research Application is not intended for in vitro diagnostic or clinical use, but is intended solely for use in the research setting, for example university or pharmaceutical development. These applications are described as Research Applications or Research Use Only.
