In vitro diagnostic medical device means any medical device, including reagents, reagent products, calibration materials, control materials, kits, instruments, devices, equipment or systems, intended by a manufacturer for in vitro examination of samples obtained from the human body, including blood and tissue donors, whether used alone or in combination. The in vitro diagnostic industry has emerged with the development of modern laboratory medicine, which in turn has led to the rapid development of laboratory medicine, basic medicine and other disciplines.
Medical equipment is the medical, scientific research, teaching, institutions, clinical disciplines work the most basic elements, namely, including professional medical equipment, including home medical equipment. Medical equipment more advocated classification method has three major categories, namely, diagnostic equipment, treatment equipment and auxiliary equipment. For reference.