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The MySet™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Over-The-Counter Use.

The MySet™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The MySet™ Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test employs a unique combination of monoclonal-dye conjugate and mouse monoclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a red color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a red color band, demonstrating that the test is functioning correctly.