2, in vitro diagnostic products are mainly composed of diagnostic equipment (instruments) and diagnostic reagents. According to China's State Food and Drug Administration (SFDA) "Medical Device Classification Catalog" standard, in vitro diagnostic equipment belongs to the class of clinical testing and analysis instruments.
3, the rapid development of in vitro diagnostic technology, from the gene level of gene sequencing, SNP screening, point mutation gene diagnosis, to the protein level of a variety of biomarkers (biomarker) detection, to the cellular level of the circulating tumor cell test (CTC), thin layer liquid-based cytology (TCT), and then to the organization of the level of PET / CT and so on. In general, in vitro diagnosis is developing in the direction of simpler, faster, non-invasive, and multi-informatics.
4. In vitro diagnostics are extremely helpful for people's medical checkups, chronic disease management, and monitoring of serious diseases.