Device Dossier
LG global for Fertilization - In vitro fertilization culture medium
Device Dossier for LG global for Fertilization - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor…
- GMDN category: In vitro fertilization culture medium
Intended purpose
For holding human cumulus-oocyte complexes prior to IVF or ICSI and for conventional IVF. 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-equilibrated in a CO2 incubator at 37 degrees C. CO2 levels should be adjusted to attain the suggested pH range for global for Fertilization of 7.3 ± 0.1. The product is used according to standard principles within the ART laboratory.