Genobio Successfully CE Marked for Its Monkeypox Virus PCR Test

Tianjin, China – July 28, 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-IVD mark for their newly developed Monkeypox Virus Molecular Detection Kit (Real-time PCR). Monkeypox Virus Molecular Detection Kit (Real-time PCR) is used for in vitro quantitative detection of F3L gene from Monkeypox virus in skin lesions, vesicles and pustular fluid, dry crusts and other specimens from individuals who are suspected of Monkeypox virus infection by their healthcare provider.

Due to the accuracy and sensitivity, polymerase chain reaction (PCR) is recommended by World Health Organization (WHO) for detecting Monkeypox virus. Skin lesions, vesicles and pustular fluid and dry crusts is used as sample in Monkeypox Virus Molecular Detection Kit (Real-time PCR). Those are specimens recommended by WHO. The reagents are in Lyophilized powder format. It could reduce storage difficulty. The kit can be transported at room temperature, which minimizing transportation cost.

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About Era Biology Group

Era Biology Group established in 1997. It is a leader and pioneer of invasive fungal disease diagnostic field. Headquarter is located in Tianjin, China. Until 2022, eight wholly-owned subsidiaries are 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 have been awarded the Marine Economic Innovation Development Demonstration Project by 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 National Center for Clinical Laboratories. Globally, Era Biology have 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.

8.内毒素化学发光-03

Post time: Jul-29-2022