Device Dossier

ORIGIO Gradient 40/80 - In vitro fertilization culture medium kit

Device Dossier for ORIGIO Gradient 40/80 - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III, sponsor…

Intended purpose

For the efficient separation of motile sperm by the density gradient method. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

ORIGIO Gradient 40/80 (8402) consists of two vials of medium with different concentrations of colloidal silica particles coated with silane (ORIGIO Gradient 40% and ORIGIO Gradient 80%). When separating viable from non-viable spermatozoa, the sperm is centrifuged into a density gradient made of the two media. The viable spermatozoa will be found in the pellet, while the non-viable spermatozoa will be "trapped" in the interphase between the 40% and the 80% medium.

TGA Public Summary