This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, or determine genetic carrier status.
This list includes nucleic acid-based companion diagnostic tests. A full list of FDA cleared or approved companion diagnostic devices is maintained on a separate page at In Vitro Companion Diagnostic Devices.