Circulating tumour cell separation system channelling instrument IVD
Definition
An electrically-powered, semi-automated laboratory instrument intended to be used for the separation and collection of circulating tumour cells of a specified size and/or deformity from a whole blood specimen using a mechanical separation method (e.g., microfluidics). It is a software-operated instrument with pneumatic and hydraulic components (e.g., reservoir bottles, tubes) which channels the blood specimen through a microfluidic cassette (not included), where the circulating tumour cells are concentrated and contained for subsequent in vitro diagnostic analysis.