Device Dossier
Haematological concentrate system centrifuge
Device Dossier for Haematological concentrate system centrifuge (Haematological concentrate system centrifuge, Class IIa, sponsor Emergo). ARTG record,…
- GMDN category: Haematological concentrate system centrifuge
Intended purpose
This device is designed to be used in the clinical laboratory or intraoperatively at point of care to separate the different components of blood, i.e. blood cells and plasma, for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood or a small mixture of blood and bone marrow. The plasma and concentrated platelets can be used for diagnostic tests. Additionally, the platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements. The platelet poor plasma can be mixed prior to application to an orthopedic site as deemed necessary by the clinical use requirements.