Device Dossier

LG global with HEPES - In vitro fertilization culture medium

Device Dossier for LG global with HEPES - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG…

Intended purpose

Embryo washing and handling. This product is for Assisted Reproductive Technology (ART) laboratory procedures. The product should only be used by professionals trained in ART treatment.

Functional description

Prior to use, this medium should be supplemented with an exogenous protein source, which must have local regulatory approval as protein supplement for media used in human ART. Prior to use, this medium must be pre-warmed to 37 degrees C. The warming period depends on the volume of medium and oil overlay. The product is used according to standard principles within the ART laboratory.

TGA Public Summary