What are in-vitro diagnostic reagents?-Your Health

What are in-vitro diagnostic reagents?

Published:

2024-04-11

In vitro diagnostic reagents are in vitro diagnostic reagents managed in accordance with medical device regulations. They are classified into Class III, Class II, and Class I products based on the level of product risk.

In vitro diagnostic reagents are managed as medical devices and are classified into Class III, Class II, and Class I products based on their risk levels.

1. Class III

Includes reagents related to the detection of pathogenic antigens, antibodies, and nucleic acids; reagents related to blood type and tissue typing; reagents related to human gene testing; reagents related to hereditary diseases; reagents related to the detection of narcotic drugs, psychotropic drugs, and medical toxic drugs; and reagents related to the detection of therapeutic drug targets, etc.

2. Class II

Other products, excluding those explicitly classified as Class III or Class I, are Class II products. These primarily include reagents used for protein detection, carbohydrate detection, hormone detection, enzyme detection, ester detection, and vitamin detection, etc.

3. Class I

Microbial culture media (not used for microbial identification and drug sensitivity testing). Sample processing products, such as hemolytic agents, diluents, and staining solutions, etc.

In vitro diagnostic reagents include reagents, reagent kits, and calibrators used for in vitro testing of human samples. These can be used independently or in combination with other instruments, appliances, and equipment to assist in disease diagnosis. It is recommended to consult with a doctor before undergoing any tests to prepare appropriately and improve the accuracy of the results.

Keywords:

Detection

Your Health

Learn more about industry trends

2025/04/07

Good news for PCI patients - antiplatelet drug testing

Atherosclerosis thrombosis is the basis of many cardiovascular and cerebrovascular events, and platelets play an important role in the formation and development of atherosclerosis thrombosis.

2025/04/07

Unleashing the Arsenal of Antiplatelet Drugs

Atherosclerosis thrombosis is a systemic disease affecting the cardiovascular, cerebrovascular, and peripheral arteries, in which platelet activation and aggregation play an important role in the formation and development of atherosclerosis thrombosis.

2024/04/11

Main types and technical principles of in vitro diagnostic reagents

In vitro diagnostic reagents are widely used in medical research and clinical testing. Due to their stable quality and reliable effects, they not only provide a basis for research and diagnosis and treatment but also provide technical data for disease prevention and control. In vitro diagnostic reagents are numerous and involve many disciplines. Due to the increasing interdisciplinary crossover and the emergence of new technologies, it is difficult to classify them simply based on any single principle.

2024/04/11

What are the five major categories of in vitro diagnostic reagents?

In vitro diagnostic reagents include colloidal gold, enzyme-linked immunosorbent assay (ELISA), nucleic acid amplification, biochips, and chemiluminescence immunoassay.