Device Dossier

ORIGIO Handling 8311 (with Phenol red) - In vitro fertilization culture medium

Device Dossier for ORIGIO Handling 8311 (with Phenol red) - In vitro fertilization culture medium (In vitro fertilization culture medium, Class III,…

Intended purpose

ORIGIO Handling is intended for ART procedures (assisted reproduction techniques) involving handling and micromanipulation of gametes and embryos outside a CO2 incubator. Indications include oocyte retrieval (incl. follicle flushing), gamete (oocyte/sperm) and embryo washing, and micromanipulation procedures including ICSI, assisted hatching, polar body and trophectoderm biopsy.

Functional description

ORIGIO Handling (8311) is designed to provide optimal physiological and chemical conditions for the gametes and embryos during in vitro ART procedures taking place outside the CO2 incubator. A red, non-viscous solution used for various ART procedures as described in the intended purpose.

TGA Public Summary