Device Dossier
SAGE 1-Step GM-CSF - In vitro fertilization culture medium
Device Dossier for SAGE 1-Step GM-CSF - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III, sponsor Origio). ARTG…
- GMDN category: In vitro fertilization culture medium
Intended purpose
For culture through to the blastocyst stage. Should 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
Provided in standard design glass bottles with a screw cap, containing a non-viscous red coloured liquid. Provides a liquid environment with physiological osmolality and pH, and components supporting the biological function of embryos during in vitro culture through to blastocyst stage, and during the transfer procedure. Incorporates human albumin solution (HAS), gentamicin sulphate (antibiotic) and recombinant human GM-CSF (sargramostim), all considered as ancillary medicinal substances.