Clinical Research Directory

Inclusion Criteria: * Willing and able to provide written informed consent and/or assent as required by the reviewing IRB or IEC. Experimental Bill of Rights will also be documented for all study subjects enrolled in applicable states. * ≥14 years of age at the time of enrollment. * Subject has a penis at the time of enrollment. * Able to read and understand instructions provided for the study. * Willing and able to follow all study procedures, including performing self-collection of one urine sample, running the sample on a Visby test, and using the Visby App to interpret the test results. Exclusion Criteria: * Have a medical condition, serious illness, or other circumstance that, in the investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures. * Have consumed oral or intramuscular or intravenous antibiotics, within 48 hours prior to enrollment. * The subject has urinated within the last one (1) hour prior to urine sample collection. * Have an in-dwelling catheter or practices intermittent catheterization for urinary drainage. * Have been previously enrolled in this study.