Device Dossier

Haematological concentrate system kit, platelet concentration

Device Dossier for Haematological concentrate system kit, platelet concentration (Haematological concentrate system kit, platelet concentration, Class…

Intended purpose

The system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP is prepared prior to application to a local area of soft tissue or hard tissue (including bone) site as deemed necessary by the clinical use requirements. And its intended use is for the application of PRP in order to achieve the stimulation of soft tissue and hard tissue (including bone) and acceleration of soft tissue and hard tissue (including bone) healing.

TGA Public Summary