The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers’ in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2.
College of American Pathologists (CAP) Microbiology Committee Perspective: the Need for Verification Studies
Journal of Clinical Microbiology | March 24, 2020 | Volume: 58 | Issue: 4 | Pages: No page available