In-Vitro Diagnostic (IVD) tests are a subset of medical devices.

In-vitro diagnostic tests are used for in-vitro examination of specimens derived from the human body to provide information for screening, diagnosis, or treatment monitoring purposes.

An IVD test may include reagents provided either in kit format or separately, as well as calibrators, and controls.

In vitro testing may be performed on a variety of instruments ranging from small, hand held tests to complex laboratory instruments.