Genobio Successfully Registered CE-IVDR for Its Instruments

Genobio Successfully Registered CE-IVDR for Its Instruments

Tianjin, China – October 7, 2022 – Genobio Pharmaceutical Co., Ltd, a wholly-owned subsidiary of Era Biology Group, which is a leader and pioneer of invasive fungal disease diagnostic field since 1997, has received CE-IVDR certification for self-developed and produced instruments:

● Full-Automatic Chemiluminescence Immunoassay System (FACIS-I)

● Fully Automatic Kinetic Tube Reader (IGL-200)

● Immunochromatography Analyzer

● Full-Automatic Molecular Diagnostic Platform

● Portable Thermostatic Nucleic Acid Amplification Analyzer


About Era Biology Group

Era Biology Group was established in 1997. It is a leader and pioneer of the invasive fungal disease diagnostic field. ​The headquarter is located in Tianjin, China. Until 2022, eight wholly-owned subsidiaries were established in Beijing, Tianjin, Suzhou, Guangzhou, Beihai, Shanghai and Canada. In China, Era Biology is the leading enterprise in the field of in vitro fungus diagnosis. Era Biology has been awarded the Marine Economic Innovation Development Demonstration Project by the National Oceanic Administration and Ministry of Finance. In 2017, Era Biology drafted the domestic industrial standard of “Fungus (1-3)-β-D-Glucan Test" together with the National Center for Clinical Laboratories. Globally, Era Biology has passed the authentication of CMD ISO 9001, ISO 13485, Korea GMP and MDSAP, and the products have certificates of CE, NMPA and FSC. Sticking to the slogan “Innovation for better health”, Era Biology insists on high quality and strict control while continuously conducting further research and development.

Product Advantages

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Post time: Oct-25-2022