Device Dossier
BlastGen - In vitro fertilization culture medium
Device Dossier for BlastGen - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG record,…
- GMDN category: In vitro fertilization culture medium
Intended purpose
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 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.