What are the in vitro diagnostic reagents?

In vitro diagnostic reagents are used to detect human samples (various body fluids, cells, tissue samples, etc.) in vitro. In modern medicine, in vitro diagnostic reagents are often used for disease prevention, clinical diagnosis and treatment. In China, most in vitro diagnostic reagents are managed according to medical devices, and there are two or three types, and a few are managed according to drugs. In vitro diagnostic reagents are divided into three categories. Let's see what in vitro diagnostic reagents include. 1. What is an in vitro diagnostic reagent?

In vitro diagnostic reagents refer to reagents, kits, calibrators (substances) and quality control products (substances) that can be used alone or in combination with instruments, meters, equipment or systems to detect human samples (various body fluids, cells, tissue samples, etc.) in vitro. ) disease prevention, diagnosis, treatment monitoring, prognosis observation, health status assessment and genetic disease prediction in the process.

At present, in vitro diagnostic reagents are basically needed for disease prevention and clinical diagnosis and treatment. Whether it is the three routine tests of hematuria and stool, the identification of virus and bacterial infection, or the examination of heart, liver, kidney, blood vessels and immune function, it is inseparable from in vitro diagnostic reagents.

Two, in vitro diagnostic reagents belong to several types of medical devices?

In vitro diagnostic reagent belongs to a kind of medical device, which is called in vitro diagnostic medical device together with in vitro diagnostic device. What kinds of medical devices do in vitro diagnostic reagents belong to?

It is understood that in China, most in vitro diagnostic reagents are managed according to medical devices, and some in vitro diagnostic reagents are managed according to drugs. In terms of drugs, in vitro diagnostic reagents used for blood screening and radionuclides labeled in vitro diagnostic reagents do not belong to medical devices, while others belong to medical devices. According to the situation, in vitro diagnostic reagents are included in the second and third types of medical devices.

3. What are the in vitro diagnostic reagents?

Like the classification of medical devices, the types of in vitro diagnostic reagents are also divided into three categories according to the product risk level:

1, the first in vitro diagnostic reagent

(1) Microbial culture medium (not used for microbial identification and drug sensitivity test).

(2) Products used for sample treatment, such as hemolytic agent, diluent, dyeing solution, etc.

2, the second kind of in vitro diagnostic reagents

(1) protein detection reagent.

(2) reagents for sugar detection.

(3) hormone detection reagent.

(4) Enzyme detection reagent.

(5) ester detection reagent.

(6) Vitamin detection reagent.

(7) Inorganic ion detection reagent.

(8) reagents for detecting drugs and drug metabolites.

(9) autoantibody detection reagent.

(10) reagents used for microbial identification or drug sensitivity test.

(1 1) reagents for detecting other physiological, biochemical or immune function indicators.

3, the third kind of in vitro diagnostic reagents

(1) reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens.

(2) reagents related to blood type and tissue matching.

(3) reagents related to human gene detection.

(4) reagents related to hereditary diseases.

(five) 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).