In vitro diagnostics and IVD (In Vitro Diagnosis), refers to the outside of the body, through the human samples (such as blood, body fluids, tissue) for testing and access to clinical information, products and services so as to determine disease or bodily functions.
Internal in vitro diagnostic (IVD) development started late, until 1985 developed China's first batch of homemade biological diagnostic reagents. But benefited from medical consumption levels increase, health care reform push, the State industrial policy support, and itself has a disposable feature, will 15%~20% the IVD industry growth rate. IVD (In Vitro Diagnosis), Chinese translation for in vitro diagnostics, refers to the outside of the body, based on samples of the human body (blood, body fluids, tissue, etc) obtained clinical diagnostic testing products and services, including reagents, reagent products and calibration materials, control material, Kit, instrument, apparatus, equipment or systems. According to China's State food and Drug Administration (SFDA) of the category of medical devices standard clinical laboratory analytical instruments-6840 of class.