Motile sperm concentration IVD, kit, imaging, self-testing

Definition

A collection of devices intended to be used to visualize sperm and calculate motile sperm concentration in a semen specimen for the assessment of male fertility. It includes a magnifying lens and application software. The lens is intended to be attached to a compatible mobile communication device with a camera (not included) which runs the software to enable visualization and analysis of sperm in the semen specimen. It also includes materials to collect, process, and display the semen specimen. It is available [non-prescription] over-the-counter (OTC) for use in the home.

GUDID devices

31

Last updated

2026-06-04 19:44:10