Chemiluminescence belongs to several types of medical devices.

Chemiluminescence immunoassay analyzer is a second-class 6840 clinical laboratory analytical instrument. According to Article 4 of the Measures for the Supervision and Administration of Medical Device Management, medical device management should be classified according to the risk degree of medical devices. There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.