Device Dossier

EmbryoGen/BlastGen - In vitro fertilization culture medium kit

Device Dossier for EmbryoGen/BlastGen - In vitro fertilization culture medium kit (In vitro fertilization culture medium kit, Class III, sponsor Origio).…

Intended purpose

EmbryoGen is for culture through to cleavage stage. Should also be used for embryo transfer. BlastGen is for embryo culture from Day 3 through to the blastocyst stage. Should also be used for embryo transfer. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The products should only be used by professionals trained in ART treatment.

Functional description

Prior to use the medium must be pre-equilibrated in a CO2incubator at 37 degrees C. pH should be measured and adjusted using CO2 to attain the suggested pH range for embryo development. The suggested pH range for EmbryoGen is 7.3 ± 0.1 and for BlastGen 7.35 ± 0.1. The time required to achieve full equilibration depends on the volume of medium and overlay. The product is used according to standard principles within the ART laboratory, as well as for the embryo transfer procedure.

TGA Public Summary