immunofluorescence reagents
  • Xiamen Biotime Monkeypox Virus (MPV) nucleic acid IVD kit was certified by the UK MHRA
    Xiamen Biotime Monkeypox Virus (MPV) nucleic acid IVD kit was certified by the UK MHRA August 02, 2022
    Recently, Xiamen Biotime Biotechnology Co., Ltd Monkeypox Virus (MPV) nucleic acid IVD kit (fluorescent PCR method) was certified by the UK MHRA. On July 23, the World Health Organization declared the monkeypox epidemic a "Public Health Emergency of International Concern", which is the highest level of alert issued by the World Health Organization for a global public health emergency, and also means that the current COVID-19 pandemic and the monkeypox epidemic are at this alert level at the same time. Xiamen Biotime Biotechnology Co., Ltd Monkeypox virus nucleic acid test kit adopts rapid PCR amplification mode, and the test kit can obtain the detection result in 40 minutes; it has high specificity and sensitivity, and can detect low concentrations of virus in the sample. There is no cross-reaction between monkeypox virus detection and smallpox virus, vaccinia virus, vaccinia virus, etc. At present, Xiamen Biotime Biotechnology has stockpiled diagnostic technologies such as immunofluorescence, chemiluminescence, molecular diagnosis, electrochemistry, and colloidal gold, contributing "Biotime power" to global public health prevention and control.
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  • Blockbuster!Xiamen Biotime has been awarded MDSAP certification
    Blockbuster!Xiamen Biotime has been awarded MDSAP certification July 22, 2022
    Recently, Xiamen Biotime Biotechnology Co., Ltd. completed the Medical Device Single Audit Program (MDSAP) and obtained the MDSAP certification issued by the international certification body SGS MDSAP Certification Program It is co-sponsored by members of the International Medical Apparatus Regulators Forum (IMDRF) and recognized and joined by regulators in the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW). A new audit procedure allows medical apparatus manufacturers to undergo only one quality management system audit to meet the standards and regulatory requirements of the above five countries. The audit work is carried out by an audit body authorized by the regulatory agencies of the five countries. As a high-tech enterprise specializing in the research and development, production and sales of in vitro diagnostic reagents and instruments, Xiamen Biotime Biotechnology Co., Ltd. always adheres to the quality policy of 'product-oriented, innovation-oriented, management-oriented, and service-oriented', and strictly controls product quality management. Obtaining the MDSAP certification will further bring advantages and convenience to Xiamen Biotime's products to obtain overseas market access qualifications, and accelerate the pace of the company's global development strategy. In the future, Xiamen Biotime Biotechnology Co., Ltd. will continue to help the global epidemic prevention and control work, be committed to providing high-quality in vitro diagnostic products to more countries and regions around the world, and contribute to the development of the global biomedical industry.
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  • Biotime Pharmaceutical (Shanghai) Co., Ltd. was officially put into operation on August 8 2022
    Biotime Pharmaceutical (Shanghai) Co., Ltd. was officially put into operation on August 8 2022 August 08, 2022
    In the Xiamen Trade Fair on 8th Sep. 2021, Xiamen Biotime Biotechnology Co., Ltd. released new drugs development strategy, planning to invest more than 1 billion yuan of scientific research funds in the medical and health field in the next three years, and at the same time set up another 1 billion yuan to focus on investment Funds mainly in the medical and health field. Xiamen Biotime Biotechnology surpassed the IVD boundary and entered the field of new drugs, which attracted the attention of the industry, and quickly reached extensive strategic cooperation with Hangzhou Adlai Nortye Biopharma Co., Ltd. and Shanghai Medicilon Inc. Less than a year, in the beginning of autumn in 2022, Biotime Pharmaceutical (Shanghai) Co., Ltd. was officially put into operation on August 8. At the unveiling ceremony, Yu Jianping, Deputy General Manager, delivered a speech instead of Chief Executive Zhang Guofeng. From Biotime to Biotime Pharmaceutical, from diagnosis to treatment, we have made a big leap. Today we are here to witness an important historical moment of Biotime Pharmaceutical. I believe that with everyone's support, Biotime Pharmaceutical will get a better tomorrow. Afterwards, Lin Baode, head of R&D of Biotime Pharmaceutical, delivered a speech. Today, Biotime Pharmaceutical may be a little spark, but we believe that it will definitely ignite and attract the attention of the industry in the future! Biotime Pharmaceutical Shanghai R&D Center is located on Cailun Road, Zhangjiang High-tech Park, which is known as China Pharmaceutical Valley. The research center that covers an area of about 700 square meters has invested nearly 50 million yuan to configure various high-end precision instruments and equipment, and built a modern laboratory.
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  • Biotime to Inaugurates Academic Exchange Center in Xiamen
    Biotime to Inaugurates Academic Exchange Center in Xiamen June 09, 2022
    On June 6, 2022, the Opening Ceremony of Biotime Academic Exchange Center was successfully held. Associate Dean of Shanghai Academy of Experimental Medicine, President of the National Association of Health Industry and Enterprise Management, Professor Song Haibo, Director of the Fujia Provincial Center For Clinical Laboratory, President of the Fujian Medical Association, Chen Falin, Xiamen University Life Sciences School Professor, Director of the Xiamen University - Biotime Research Center for Translational Medicine Zhang Yongyou and other guests, Chairman of Biotime Zhang Guofeng, Co-CEO Yin Peng, Vice General Manager Huang Jianguo and Zhuang Yanghuang and other business leaders attended the ceremony. Vice General Manager Zhuang Yanghuang led the ceremony Vice General Manager Zhuang said that Biotime Academic Exchange Center is expected to create opportunities and promote exchanges for the experts across the country, and this is also an opportunity for us, to do our best and strive for better future. Professor Song Haibo, President of the Fujian Medical Association Chen Falin, Deputy Director of Xiamen University School of Public Health, Director of the Center for Clinical Laboratories of Xiamen Humanity Hospital, Zhang Zhongying, together with Co-CEO of Biotime Yin Peng officially unveiled the commemorative plaque of the Biotime Academic Exchange Center. Co-CEO of Biotime Yin said that Biotime Academic Exchange Center is a platform at a higher level among leading experts and research communities at university, utilize Biotime’s production capacity to transform R&D achievements into product, as the mission we believe and keep pursuing,“Technology for Health” Director of the Fujian Provincial Center For Clinical Laboratory, President of the Fujian Medical Association, Chen Falin delivers the opening speech On the afternoon of June 6, the 1rst Session of Academic Salon was held.Director Chen said that productivity blends with creativity is a necessity in the development of Medical Laboratory, the establishment of Biotime Academic Exchange Center is to better apply the In-Vitro Diagnostic products into practice. Co-CEO of Biotime Yin Peng shares the trend in Translational Medicine and Biotime’s technology platforms and products Xiamen University Life Sciences School Professor, Director of the Xiamen University - Biotime Research Center for Translational Medicine Zhang Yongyou shares the product development of In-Vitro Diagnostic product with AI-Powered Design Biotime Academic Exchange Center provides a higher level platform for leading experts, exerts its will and capability on In-Vitro Diagnostic industry and takes the lead to construct a sustainable ecosphere and advance the combination of production and product development.
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  • Biotime to Invest 180 Million Dollars in POCT Industrial Park for New Diagnostic Production, Research and Development
    Biotime to Invest 180 Million Dollars in POCT Industrial Park for New Diagnostic Production, Research and Development June 06, 2022
    On June 6, 2022, the Foundation Laying Ceremony of Biotime POCT Industrial Park Constructional Project was successfully held. Vice Mayor of Xiamen Government Huang Xiaozhou, Director of the Committee of Haicang Taiwanese-invested Investment Zone, Governor of the Haicang District Gong Jianyang, Associate Dean of Shanghai Academy of Experimental Medicine, President of the National Association of Health Industry and Enterprise Management, Professor Song Haibo and other leaders and guests, Chairman of Biotime Zhang Guofeng, Co-CEO Yin Peng, Vice General Manager Huang Jianguo and Zhuang Yanghuang and other business leaders witnessed this important moment. the Foundation Laying Ceremony of Biotime POCT Industrial Park Constructional Project the Chairman of Biotime, Zhang Guofeng delivers the opening speech The Chairman Zhang said that Biotime powered by innovation and stick with pragmatic approach since it was established, we believe and keep pursuing the mission of “Technology for Health” . Biotime have been listed in the “little giant” Enterprises of the Ministry of Industry and Information Technology and awarded as the “High-Tech Enterprise” and many others. With strong government support and Biotime’s own effort, it has now became the core drives in the fight against the coronavirus pandemic. This project marked a new chapter for Biotime, it will raise the capacity for pursuing product development, have a greater efficiency to increase output, construct a sustainable ecosphere for the industry and benefit in all aspects. This special time provide Biotime an extraordinary opportunity and we will actively take action and remain persistent and determined in our role in the industry and society. Deputy Director of the Committee of Haicang Taiwanese-invested Investment Zone, Zhang Chunjie delivers the speech Director of Xiamen Administration for Market Regulation, Xu Guohua delivers the speech Associate Dean of Shanghai Academy of Experimental Medicine, President of the National Association of Health Industry and Enterprise Management, Song Haibo delivers the speech the Foundation Laying Ceremony of Biotime POCT Industrial Park Constructional Project Biotime POCT Industrial Park is located in the southwest of the intersection of Maolin Road and Haixiang Avenue in Haicang District. It is divided into two plots and it covers a total area of about 86855.743 square metres, of which 35587.110 square metres is used for Plot A, and 51268.633 square metres for the Plot B. A total investment of nearly 180 million dollars is expected to be made in the industrial park by 2024. Rendering of Biotime POCT Industri...
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  • Biotime's SARS-CoV-2 Antigen Rapid Qualitative Test has received approval from the China's National Medical Products Administration (NMPA)
    Biotime's SARS-CoV-2 Antigen Rapid Qualitative Test has received approval from the China's National Medical Products Administration (NMPA) May 23, 2022
    May 20, 2022, Biotime announced that its SARS-CoV-2 Antigen Rapid Qualitative Test has received approval from the China's National Medical Products Administration (NMPA). The details are as follows: The SARS-CoV-2 Antigen Rapid Qualitative Test has also obtained CE mark for self-testing, which is another effective tool for the company to actively support global anti-epidemic. It can be operated by individuals who collect the front nasal swab sample by themselves, and the result can be quickly delivered in 20-30 minutes. Since the outbreak of COVID-19, Biotime as a global innovation-driven healthcare company has fully integrated its business and global resources with timely response and actively undertaking the social responsibilities in combating COVID-19 pandemic control and minimizing its impact. Biotime has developed a growing number of diagnostic solutions that help to diagnose and detect the infection, and we will continue to play our role and increase production to support availability of tests globally.
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  • Biotime's COVID-19 Ag & FluA/B Combo Test Obtains CE Mark for Self-testing
    Biotime's COVID-19 Ag & FluA/B Combo Test Obtains CE Mark for Self-testing May 18, 2022
    Biotime announced today that, it had now achieved CE Marking for its COVID-19 Ag & Flu A/B Combo Test from the European certification body CeCert to be used as a consumer self-test in the European Union (EU) and other regions that recognized the CE Mark. The details are as follows:  The test detects N protein from SARS-CoV-2, influenza A and influenza B directly from a nasal swab with results in 15 minutes from sample application in people with COVID-19 symptoms or influenza A or influenza B infection. The test has the advantage of being consistent in sensitivity and easy handling, it well meets the needs of epidemic prevention and control at home in various countries. Biotime will keep supporting the cause of global COVID-19 prevention and control, and actively respond to the market demand for testing products in COVID-19.
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  • Biotime's SARS-CoV-2 Antigen Test Obtains CE Mark for Self-testing
    Biotime's SARS-CoV-2 Antigen Test Obtains CE Mark for Self-testing March 16, 2022
    Biotime's SARS-CoV-2 Antigen test obtains CE mark for self-testing, the details are as follows: The SARS-CoV-2 Antigen Rapid Qualitative Test that has completed CE certification, this time is another effective tool for the company to actively support global anti-epidemic. It can be operated by individuals who collect the front nasal swab sample by themselves, and the result can be quickly obtained in 20-30 minutes, which is convenient for individuals and families to quickly detect Covid-19, well meets the needs of epidemic prevention and control at home in various countries, and further enriches the Biotime COVID-19 Solution. The company will fully support the cause of global COVID-19 prevention and control, and actively respond to the market demand for testing products in COVID-19.
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