Device Dossier
SAGE 1-Step - In vitro fertilization culture medium
Device Dossier for SAGE 1-Step - 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 culture through to the blastocyst stage. Can also be used for embryo transfer. 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, must be pre-equilibrated in a CO2 incubator at 37degrees C. pH of the medium should be adjusted using CO2 to attain the suggested pH range for optimal embryo development. Suggested pH range for SAGE 1-Step is 7.3 ± 0.1. Designed for uninterrupted culture, without media change, until the desired developmental stage of the embryo has been reached. The product is used according to standard principles within the ART laboratory, as well as for the embryo transfer procedure.