HemaTrate® Blood Filtration system

The HemaTrate® Blood Filtration System (Cook Regentec) is a medical device intended for use in the point-of-care intra-operative or clinical laboratory for the rapid preparation of a concentrate of nucleated cell concentrate total (TNC) 20 to 120 mL of anticoagulated blood for use in human cell therapy applications.

The HemaTrate® Blood Filtration System uses a selective gravity filtration system separation technology that separates specific cell populations, useful for the concentration of autologous total nucleated cells from anti-coagulated peripheral blood.

During production, each filter is subjected to conformity and integrity control tests. All materials of parts intended for contact with fluids meet USP 88 in vitro biological reactivity tests and/or relevant sections of the ISO 10993 series of standards.  The system is designed and manufactured according to quality systems compliant with ISO 9001:2015 and ISO 13285:2016 standards and with Directive 93/42/EEC for Medical Devices.

The HemaTrate® Blood Filtration System device is contained in the HemaTrate® Procedure Pack kit produced by Betatex Spa to Athena specifications.

HemaTrate® Procedure Pack is an assembled, sterile kit that contains all the accessories necessary for use to improve the reproducibility of the method considering the biological variability of the patient.