, as an independent branch of medical devices, has its own unique definition and regulatory system, especially the US Food and Drug Administration (FDA
) and European Union (EC
). IVD mainly includes instruments, reagents or systems for in vitro diagnostics. However, the situation in China is different. IVD is not independently distinguished and defined, that is, there is no concept of IVD. The products included in the international IVD concept are broken down and belong to medical devices (MD), in vitro diagnostic reagents (IVD Reagents) and medicines.
In China, except for in vitro diagnostic reagents for blood source screening and the use of radionuclide-labeled in-vitro diagnostic reagents that are defined as drug management, all other IVD products are under medical device (MD)
There are some types of IVD diagnostics: Biochemical diagnostic reagents, immunodiagnostic reagents, molecular diagnostic reagents, microbiological diagnostic reagents, urine diagnostic reagents, coagulation diagnostic reagents, hematology, flow cytometric diagnostic reagents and Lateral Flow Immunodiagnostic, etc.
There are lots of Lateral Flow IVD test kit widely used in our daily life. Easy to buy amazon, ebay, drug store, supper market, etc. For example:
FDA Approved Home Cholesterol Test Kit
HCG test for pregnancy
LH test for ovulation detection
HIV Test strip
Malaria Test strip
Test kit for detecting drug residues in egg, meat, milk, fish, rice, etc.
Test kit for detecting diseases in cattle, dog, cat, goat, sheep, etc.
Beckman Coulter / Danaher
Cepheid / Danaher
Danaher Corp. (including Radiometer A/S)
Instrumentation Laboratory / Werfen
LabCorp, Laboratory Corporation of America
Ortho Clinical Diagnostics
Roche Diagnostics (including Ventana Medical Systems)
Sysmex CorporationThermo Fisher Scientific
work in Lateral Flow Immunodiagnostic research & development more than 12 years. Especially in Colloidal gold & Fluorescence platform, we had launched 8 types test kit
basic on both platform. We focus on food safety test kit, but also pay more attention and research in IVD medical devices for human beings.