Home semen collection kit IVD

Definition
A collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen receptacle with a preservative, a pipette, instructions for use, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.
GUDID devices
2
Last updated
2023-07-19 07:00:59

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00868586000285General Purpose Reagent Delayed Semen Analysis MediaQuest DiagnosticsPPM2023-07-11
09309000599004Sapyen At-Home Male Fertility Analysis KitVITO HEALTH PTY LTD12023-04-13