IVD products are known as "in vitro diagnostic products". IVD refers to medical devices, in vitro diagnostic reagents, and drugs. IVD, as a branch of medical devices, has unique definitions and regulatory supervision.
The in vitro diagnostics industry and laboratory medicine constitute an organic whole that is not only different from each other but also closely related to each other. The in vitro diagnostics industry is the "tool" and "weapon" of laboratory medicine. At the same time, laboratory medicine is the "user" and "market" of the IVD industry. About 80% of clinical diagnosis information comes from IVD, and its cost accounts for less than 20% of medical expenses. IVD is an important part of diagnosis, Immunohistochemistry, treatment of human health. Medicament supplies ivd raw materials, in vitro diagnostics reagents and IVD test kits as well.
We are committed to providing the highest quality ivd diagnostics raw materials and ivd diagnostics reagents for in vitro diagnostic use only. Our in vitro diagnostic products strictly control the quality inspection, which can provide you solid, repeatable, dependable results, to meet the critical challenges faced by reagent vendors, and the verification of government agencies. The ingredient of our ivd products is exactly the same as Sigma-Aldrich, Roche, et al.
As we all know, the blood routine, urine routine, stool routine, blood sugar monitoring, anemia screening and so on that we do in the hospital all use diagnostic reagents. These diagnostic reagents are normally used without contact with the human body, so are they called "in vitro diagnostic reagents"?Nowadays, in-vitro diagnostic reagents are basically needed for disease prevention and clinical diagnosis and treatment. Whether it is the three major routine tests for hematuria and stool, the identification of viral and bacterial infections, the heart, liver, kidney, blood vessel, and immune function tests, in-vitro diagnostic reagents are inseparable.
The rapid development of IVD technology, from gene sequencing, SNP screening, point mutation gene diagnosis, to the detection of various biomarkers (biomarker) at the protein level, detection of circulating tumor cells (CTC) at the cellular level, thin layer Liquid-based cytology (TCT), then to PET/CT at the tissue level. The application prospects mainly include the following aspects: Physical examination, Chronic disease management, Critical illness monitoring.
IVD medical devices refer to samples obtained from the human body for in vitro examinations, including blood and tissue donors, any medical devices used alone or in combination, including reagents, reagent products, calibration materials, and control materials. , Kits, instruments, devices, equipment or systems.