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Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in human whole blood or serum. The blood specimen is obtained by fingerstick using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician's office. It is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.

Stat-Simple™ pylori is a colloidal-gold based immunoassay.

The Evidence Pregnancy Test is a qualitative, one-step assay for the detection of human chorionic gonadotropin (hCG) in urine. The Evidence Pregnancy Test is intended to be used by the lay consumer.

Evidence Pregnancy Test is a pregnancy test to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the eighth or ninth day after fertilization. The Evidence Pregnancy Test will detect hCG in urine as early as the first day after a missed menses. The Evidence Pregnancy Test will be made available to the lay consumer. The Evidence Pregnancy Test employs a unique combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band if hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.