A wide array of OraSure's core diagnostic tests, sample collection devices, and rapid screening tools have received official clearance, authorization, or approval from the U.S. Food and Drug Administration (FDA). This includes groundbreaking consumer-facing products like the OraQuick In-Home HIV Test, professional point-of-care infectious disease diagnostics, and various emergency-use authorizations for molecular collection kits, ensuring they meet rigorous safety and efficacy standards for public distribution.