Device Dossier

Autologous blood collection tube

Device Dossier for Autologous blood collection tube (Autologous blood collection tube, Class IIa, sponsor Evolve Medical Solutions). ARTG record,…

Intended purpose

The device is intended for the collection of autologous venous whole blood and its in vitro processing by centrifugation without the use of anticoagulant to prepare platelet-rich fibrin (PRF). The device enables temporary containment and centrifugation of whole blood to facilitate density- based separation and fibrin matrix formation. The resulting PRF is intended to be handled and used by trained healthcare professionals in accordance with accepted clinical practice, and is for non-intravenous use only.

TGA Public Summary