Category: In vitro diagnostic medical devices

In vitro diagnostic (IVD) medical devices are tools, software, and tests used to examine biological samples (blood, tissue, urine) outside the body (“in glass”) to provide crucial health information, helping diagnose, monitor, treat, or screen for diseases, conditions, or abnormalities, like pregnancy tests, COVID-19 tests, and blood glucose monitors. They range from at-home kits to complex lab equipment, forming a vital, non-invasive part of healthcare for making clinical decisions and guiding therapies.