Device Dossier

ORIGIO Gradient 90 - In vitro fertilization culture medium

Device Dossier for ORIGIO Gradient 90 - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG…

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 90 is a viscous solution of colloidal silica particles coated with silane to be diluted with ORIGIO Sperm Wash (8405) to produce different custom gradient solutions. When separating viable from non-viable spermatozoa, a gradient of the two solutions is made and after centrifugation the viable spermatozoa will be found in the pellet, while the non-viable spermatozoa will be "trapped" in the phase between the two gradient solutions.

TGA Public Summary