One category is managed in accordance with medical devices, including reagents, kits, calibrators, quality control products (substances), etc., which can be used individually or in combination with instruments, apparatuses, equipment or systems for in vitro testing of human body samples (all kinds of bodily fluids, cells, tissue samples, etc.) in the process of prevention, diagnosis of diseases, monitoring of treatments, observation of prognosis, evaluation of the state of health, as well as prediction of hereditary diseases. These include reagents, kits, calibrators, and quality control products.
The other category is regulated by drugs, including in vitro diagnostic reagents for blood screening and in vitro diagnostic reagents labeled with radionuclides, as required by national law.