Sperm concentration indicator IVD, kit, colorimetric dipstick, self-testing

Definition
A collection of reagents and other associated materials intended to be used to indicate the concentration of sperm in a semen specimen within a short period of time relative to standard laboratory testing procedures, using a colorimetric dipstick method. It is normally available [non-prescription] over-the-counter (OTC). This test is intended to be used for self-testing by a layperson in the home or similar environment, as an indicator of male fertility.
GUDID devices
7
Last updated
2022-08-03 08:24:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860001286533Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.TQK-0-12022-07-26
00862105000398TrakMEDTOX DIAGNOSTICS, INC.TZZ-0-1C2022-07-05
00862105000305Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.TTK-0-3 Rev 42022-06-13
00862105000312Men's Rapid Fertility TestMEDTOX DIAGNOSTICS, INC.TRK-0-1 Rev 42022-06-13
00860001286502TrakMEDTOX DIAGNOSTICS, INC.TTK-0-3 Rev 32021-06-23
00860001286519TrakMEDTOX DIAGNOSTICS, INC.TTK-0-1 Rev 22021-06-23
00860001286526TrakMEDTOX DIAGNOSTICS, INC.TRK-0-1 Rev 32021-06-23