Device Dossier

BlastGen / EmbryoGen - In vitro fertilization culture medium kit

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

Intended purpose

BlastGen™ is for the culture of 4-8 cell stage human embryos to the blastocyst stage. BlastGen™ may also be used for embryo transfer. EmbryoGen® is for the culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer on Day 2 or Day 3.

Functional description

A twin pack containing BlastGen & EmbryoGen. Solutions are equilibrated for a min 2 hrs in 5-6% CO2 at 37 degrees. After fertilisation in preferred medium, zygotes are transferred to EnbryoGen & placed in incubator. When ready, embryos can be transferred to uterus in EmbryoGen or washed & transferred to fresh BlastGen. Embryos are returned to incubator until Blastocyst formation on day 5 or 6 and can then be prepared and transferred to uetrus in BlastGen.

TGA Public Summary