Beijing Diagreat Biotechnologies Co., Ltd.

Beijing Diagreat Biotechnologies Co., Ltd. specializes in immunoassay test kits for detecting drugs of abuse, such as synthetic cannabinoids, methaqualone, LSD, morphine, and fentanyl. They also produce rapid diagnostic kits for infectious diseases like *Mycoplasma pneumoniae* (IgM) and typhoid (IgG/IgM). Additionally, the company manufactures kits for measuring therapeutic biologics, such as secukinumab and ustekinumab, as well as chemiluminescent substrates and fluorescence-based immunoassay reagents for laboratory use.

The company is headquartered in China, specifically in Beijing. This location allows it to operate within the regulatory framework of the country while developing and distributing its diagnostic and laboratory testing products globally.

Yes, the company’s devices are listed in the EU’s medical device registry, eudamed. This registry is used to track devices authorized for placement on the European market, ensuring transparency and compliance with EU regulatory requirements.

The company’s devices fall under EU regulatory classifications Class A, B, and C, depending on their intended use and risk level. Class A devices are generally low-risk, such as simple diagnostic reagents, while Class B and C devices involve higher risks, like immunoassay kits for detecting drugs of abuse or biologics, which require stricter regulatory oversight to ensure safety and performance.