Device Dossier

ORIGIO Sequential Cleav 8303 (Without Phenol Red) - In vitro fertilization culture medium

Device Dossier for ORIGIO Sequential Cleav 8303 (Without Phenol Red) - In vitro fertilization culture medium (In vitro fertilization culture medium,…

Intended purpose

For culture until 2-8 cell stage. Can also be used for embryo transfer. This product is for ART treatment, whether the cause of infertility is male or female. The product should only be used by professionals trained in ART treatment.

Functional description

ORIGIO Sequential Cleav is a sterile, non-viscous solution contained in a transparent PETG bottle with HDPE cap. ORIGIO Sequential Cleav is equilibrated at 37°C and 5-6% CO2 for a minimum of 2 hours with the lid on but not tightly closed. Fertilised oocytes (embryos) are cultured in ORIGIO Sequential Cleav for up to 72 hrs at 37°C and 5-6% CO2 and can then be transferred to the uterus for the women. Alternatively, embryos can be cultured further in a blastocyst medium.

TGA Public Summary