In vitro diagnostic reagents are reagents, kits, calibrators, and quality control products (substances) that can be used alone or in combination with instruments, apparatus, equipment, or systems for in vitro testing of human body samples (various bodily fluids, cells, tissue samples, etc.) in the process of disease prevention, diagnosis, therapeutic monitoring, prognostic observation, evaluation of the state of health, as well as prediction of hereditary diseases.
Reagents, kits, calibration products (substances), quality control products (substances), etc.
Nowadays, in vitro diagnostic reagents are basically needed for disease prevention and clinical diagnosis and treatment. In vitro diagnostic reagents are indispensable for the routine testing of blood, urine and stool, the identification of viral and bacterial infections, and the examination of heart, liver, kidney, blood vessels and immune function.
Two, in vitro diagnostic reagents belong to several categories of medical devices
In vitro diagnostic reagents belong to a kind of medical equipment, it and in vitro diagnostic equipment uniformly referred to as in vitro diagnostic medical devices, then in vitro diagnostic reagents belong to several categories of medical devices?
It is understood that in our country, most of the in vitro diagnostic reagents are managed in accordance with the medical device, there are some in vitro diagnostic reagents are managed in accordance with the pharmaceutical management, in accordance with the pharmaceutical management of the in vitro diagnostic reagents used for blood screening and in vitro diagnostic reagents labeled with radionuclides, these products do not belong to the medical device, and the rest of them belong to the medical device, according to the situation, the in vitro diagnostic reagents in the Class II and Class III medical devices are included.
Three, in vitro diagnostic reagents include what
and the classification of medical devices, the type of in vitro diagnostic reagents are also divided into three categories according to the degree of risk of the product:
1, the first class of in vitro diagnostic reagents
(1) microbial culture media (not used for microbial identification and drug sensitivity tests).
(2) Products for sample processing, such as hemolysate, diluent, staining solution.
2, the second category of in vitro diagnostic reagents
(1) Reagents for protein detection.
(2) reagents for sugar detection.
(3) Reagents for hormone detection.
(4) Reagents for enzyme detection.
(5) Reagents for ester detection.
(6) Reagents for vitamin detection.
(7) Reagents for inorganic ion detection.
(8) Reagents for the detection of drugs and drug metabolites.
(9) Reagents for autoantibody detection.
(10) Reagents for microbial identification or drug sensitivity testing.
(11) Reagents for the detection of other physiological, biochemical or immune function indicators.
3, the third category of in vitro diagnostic reagents
(1) reagents related to the detection of pathogenic pathogens antigens, antibodies and nucleic acids.
(2) Reagents related to blood type and tissue matching.
(3) Reagents related to human genetic testing.
(4) Reagents related to hereditary diseases.
(5) Reagents related to the detection of narcotic drugs, psychotropic drugs, and toxic drugs for medical use.
(6) Reagents related to the detection of therapeutic drug targets.
(7) Reagents related to the detection of tumor markers.
(8) Reagents related to allergic reactions (allergens).