1, the first class of in vitro diagnostic reagents refers to a low personal risk, no public **** health risk, the implementation of routine management can ensure its safety, effective in vitro diagnostic reagents, usually for the test auxiliary reagents.
2, the second category of in vitro diagnostic reagents refers to a moderate personal risk and / or public **** health risk, test results are usually one of several determinants, the occurrence of erroneous results will not endanger the life or lead to significant disability, the need for strict control of the management in order to ensure that it is safe and effective in vitro diagnostic reagents.
3, the third category of in vitro diagnostic reagents refers to a high personal risk and / or public **** health risk, to provide critical information for clinical diagnosis, the emergence of erroneous results will be a serious threat to the personal and / or public **** health and safety, need to take special measures to strictly control the management of the in vitro diagnostic reagents in order to ensure their safety and effectiveness.