Details
Device typeMotile sperm concentration IVD, kit, imaging, self-testing: 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.
FDA categorySemen Analysis Device
Device ID07290016650112
AvailabilityOver the counter
MRI safetyLabeling does not contain MRI Safety Information