In vitro diagnostics are products and services that are used outside the human body to obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) to determine disease or body function.
The IVD is a subsection of medical devices, which is subject to specific definitions and regulations. Any medical device, including reagents, reagent products, calibration materials, control materials, kits, instruments, devices, equipment or systems, intended by a manufacturer to be used for the in vitro examination of samples obtained from the human body, including blood and tissue donors, whether used alone or in combination.