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Autobio's HBsAg CLIA Microparticles Has Obtained The EU CE IVDR Class D Certificate.

Source:Autobio DiagnosticsTime:2023.09.27

Autobio's HBsAg CLIA Microparticles.jpg

Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.


CE certification is the "passport" for products from various countries to enter the EU market. In the field of in vitro diagnostic medical care, CE IVDR regulations classify products from Class A to Class D according to risk levels. CE IVDR Class D is the highest level in CE certification. Not only does the applicant company need to have a complete quality system, but also the entire process of product performance verification needs to be completed by a third-party independent laboratory in Europe, and the results should be compared with the top products at the current technical level. After a product is certified, in addition to regular annual audit supervision and batch testing of each product batch in an authoritative EU laboratory, it is also required to undergo more frequent unannounced inspections than other products.


Hepatitis B virus (HBV) infection is a worldwide public health problem and a major cause of liver cirrhosis and hepatocellular carcinoma. Hepatitis B virus surface antigen (HBsAg) is one of the serological markers of hepatitis B infection. It is mainly used in clinical practice to diagnose HBV infection, monitor disease progression, evaluate treatment response, judge efficacy, and evaluate the efficacy of new antiviral drugs in clinical trials.


At present, Autobio HBsAg CLIA Microparticle, HIV Ag/Ab Combo CLIA Microparticles, Anti-HCV CLIA Microparticles and Anti-TP CLIA Microparticles have obtained EU market access and can be sold in Europe and most countries that recognize CE.


Autobio Diagnostics adheres to the purpose of being"Committed to the promotion and advancement of medical laboratory technology, dedicated to serving human healthcare.", continuously increasing investment in innovation, enriching product lines, and providing more abundant products and services to international customers.