NOWDiagnostics’ ADEXUSDx™ hCG point-of-care test, which uses only a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests, has now been CLIA registered and classified by the U.S. Food and Drug Administration. The new hCG test is the first single-step, capillary blood hCG test requiring no equipment to receive FDA 510(k) clearance. The ADEXUSDx™ hCG Test, NOWDiagnostics’ first FDA-cleared test available in the United States, is an immunoassay used for the qualitative detection of human chorionic gonadotropin (hCG) in human whole blood, plasma or serum. The test is an early detection aid for pregnancy for health care professionals in a variety of clinical and critical care settings. Depending on the woman and her pregnancy, the ADEXUSDx™ hCG test can detect pregnancy approximately…read more.