Device Dossier

Assisted reproduction heater/incubator

Device Dossier for Assisted reproduction heater/incubator (Assisted reproduction heater/incubator, Class IIa, sponsor Origio). ARTG record, intended…

Intended purpose

Designed to grow and maintain IVF gametes and embryos. To grow and maintain cell cultures, particularly for IVF applications. The incubator will keep cells at an optimal temperature, humidity and gas content by maintaining a constant and clean environment for the embryo. Works with any defined premixed gas of choice - to achieve the proper CO2 and reduced O2 environment. To provide a temporary home for embryos and to replicate the conditions within the human body - reducing embryonic stress from temperature, humidity or pH changes.

TGA Public Summary