In Vitro Diagnostic (IVD) medical device
First off, let’s define, “in vitro.” This term refers to where a process takes place: in a culture dish; a test tube (e.g., in-vitro fertilization); or anywhere outside of the human body.
Thus, an in vitro diagnostic medical device refers to a device intended to be involved in the examination of tissue/living specimens and performs this task outside of the human body. These devices can include:
The purpose of this device is to provide information or aid in diagnosing, screening, monitoring, and predicting.