• DEEPBLUE Medical Receives FDA 510(k) Clearance

    News Oct 22, 2024

    DEEPBLUE Medical Receives FDA 510(k) Clearance
    Anhui DEEPBLUE Medical Technology Co., Ltd. is a leading manufacturer of in vitro diagnostic reagents based in China, dedicated to advancing human health through innovative solutions. Our main product lines including Infectious Disease Test, Respiratory Disease Test, Tumor Marker Test, Drug of Abuse Test, Women Fertility Test, Renal Injury Test, Virus Sampling Tube (VTM) and other POCT tests. Through continuous innovation and optimization, we aim to deliver high-performance diagnostic solutions that meet diverse clinical needs and enhance overall healthcare standards. We firmly believe that scientific and technological advancements are essential for better serving human health and improving patient outcomes. We are proud to announce that Anhui Deep Blue Medical Technology Co., Ltd. has successfully obtained FDA 510(k) clearance for our home-use early pregnancy testing products. This milestone underscores our commitment to providing safe and effective diagnostic solutions for women's health. We appreciate the continued support of our partners and look forward to making a positive impact on women's health globally. For more information, please contact us at E.mail or phone.
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  •  Explore Rapid Testing Innovations: Join Us at Afica Health 2024

    News Oct 17, 2024

    Explore Rapid Testing Innovations: Join Us at Afica Health 2024
    To Whom It May Concern, We are excited to announce that Anhui DEEPBLUE Medical Technology Co. will be exhibiting at the upcomingAfrica Health 2024, taking place from October 22-24,2024 at Cape Town International Convention Centre, South Africa. We would like to extend a warm invitation for you to visit our booth H1.C29. At Anhui DEEPBLUE Medical Technology Co., we specialize in the production of in vitro diagnostic reagents, offering a wide range of products including women’s health test, infectious disease diagnostics test, drug screening, and PCR. Our commitment to quality and innovation in medical technology aims to enhance healthcare outcomes globally. We believe that this expo presents a great opportunity for us to connect, share insights, and explore potential collaborations. Our team will be on hand to discuss our latest developments and how our products can meet your needs. Please let us know if you can make it. We look forward to the opportunity to meet you in person and discuss how we can work together to advance healthcare solutions. Warm regards, Anhui DEEPBLUE Medical Technology Co., Ltd.
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  • DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP quality management system

    News Nov 30, 2023

    DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP quality management system
    On 28th November 2023, Anhui DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP(Medical Device Single Audit Program) quality management system, and was awarded the certificate of MDSAP quality management system authentication (Certificate No.: No.QS6 003706 0004 (Certificate No. QS6 003706 0004 Rev.00). This quality management system certification brings DEEPBLUE more convenient access to the global market, which is conducive to improving product quality, safety, competitiveness and international market recognition, which will have a positive impact on DEEPBLUE's future development of the international market.
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  • Explore Rapid Testing Innovations: Join Us at CMEF 2024!

    News Sep 25, 2024

    Explore Rapid Testing Innovations: Join Us at CMEF 2024!
    To Whom It May Concern, We are pleased to invite you to visit Anhui DEEPBLUE Medical Technology Co., Ltd. at the upcoming China International Medical Equipment Fair (CMEF), taking place from October 12 to 14, 2024. This prestigious event will be held at the Shenzhen Word Bxhibition & Convention Center. At CMEF, we will showcase our latest innovations and technologies in the medical field, aimed at improving healthcare solutions. Our team will be available to discuss how our products can meet your needs and enhance patient care. We would be honored to have you visit our booth [13B16] to explore potential collaborations and to learn more about our offerings. Your presence would greatly enrich the experience and foster meaningful connections. Thank you for considering our invitation. We look forward to welcoming you to our booth at CMEF. Best regards, Anhui DEEPBLUE Medical Technology Co., Ltd.
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  • Authoritative Certification | DEEPBLUE Medical obtained the

    News Aug 31, 2022

    Authoritative Certification | DEEPBLUE Medical obtained the "Certificate of Export Commodity Brand"
    Recently, Anhui Deepblue Medical Technology Co., Ltd. (hereinafter referred to as DEEPBLUE) approved the approval of the China Council for the Promotion of International Trade CCPIT (hereinafter referred to as: CCPIT) evaluation, obtained the "Certificate of Export Commodity Brand", which is the national authority of DEEPBLUE export ability highly affirmed, is the future of the work of DEEPBLUE to further expand the overseas market, improve the international brand awareness and competitiveness of the international market. With the progress of social economy, brand building is particularly important in the process of enterprise development. Brand is an intangible asset of an enterprise, which reflects the economic strength, development level and overall image of an enterprise to a certain extent, and is an advantageous weapon for an enterprise in the fierce market competition. Vigorously implementing the brand strategy can not only help enterprises to establish a good corporate image and reputation, improve the trust of customers, but also help enterprises continue to expand the market, in the competition to occupy the advantage. In recent years, DEEPBLUE has accelerated the pace of participating in global competition and created a series of brands with good reputation, which is not only related to the development of enterprises, but also a strong embodiment of enhancing the comprehensive competitiveness of DEEPBLUE. In 2017, the establishment of the International Department of DEEPBLUE marked the formal entry of DEEPBLUE into the international market. In the process of hard struggle from weak to strong, from point to surface, DEEPBLUE relies on innovative technical strength, timely delivery ability, continuous improvement of after-sales service network and continuous optimization and adjustment of brand layout, adding bricks and tiles to "Deepblue Manufacturing" bit by bit, demonstrating the brand strength of DEEPBLUE. The certificate of export commodity brand is also a "cognitive method" for DEEPBLUE, which enables DEEPBLUE to have an in-depth understanding of the current situation and shortcomings of its own development, point out the direction for further improvement and development of the enterprise, and boost the implementation of the "going out" strategy. In the future, DEEPBLUE will be combined with the Suggestions for improvement of CCPIT, further implement the strategy of brand, comprehensive brand building layout, at the same time uphold the beginner's mind, give full play to accumulate and enterprise innovation advantage, strengthen intellectual property rights achievements transformation and product iteration, perfect the system of the intellectual property rights (ipr) protection, increasing foreign propaganda and comprehensive maintenance brand awareness and reputation, DEEPBLUE will further expand the international market of products and make greater contribution to building a carrier for the health industry.
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  • DEEPBLUE Medical is actively preparing for the battle

    News Aug 20, 2024

    DEEPBLUE Medical is actively preparing for the battle
    On 14 August, the World Health Organization (WHO) declared that the monkeypox outbreak constituted a ‘public health emergency of international concern’, marking the second time since July 2022 that WHO has issued the highest level of alert for a monkeypox outbreak. Currently, the monkeypox epidemic has spread from Africa to Europe and Asia, and confirmed patients infected with the monkeypox virus have been found in Sweden and Pakistan. According to the latest data from the African Centre for Disease Control and Prevention (CDC), this year the African Union has 12 member States with monkeypox outbreaks, with a total of 18,737 reported cases of monkeypox, including 3,101 confirmed cases, 15,636 suspected cases and 541 deaths, representing a mortality rate of 2.89 per cent. What is monkeypox? (Monkeypox ,MPX) is a viral zoonosis caused by the monkey pox virus, which can be transmitted from animals to humans or between humans, with fever, rash, and swollen lymph nodes as representative symptoms. Monkeypox virus mainly invades the human body through mucous membranes and broken skin, and the sources of infection include monkeypox cases and infected rodents, monkeys and apes and other non-human primates. After infection with monkeypox virus, the incubation period is 5~21 days, mostly 6~13 days. The population is generally susceptible to the monkeypox virus, although there is a degree of cross-protection against the monkeypox virus due to the similar genetic and antigenic characteristics of the same species of orthopoxviruses that have been vaccinated against smallpox. At this stage, the main mode of transmission of monkeypox is through sexual contact among men who have sex with men, and the risk of monkeypox virus infection in the general population is currently low. What's different about this round of Monkey Pox? Since the beginning of the year, the main strain of monkeypox virus, the ‘branch II strain’, has caused a major global outbreak. Worryingly, the proportion of recent cases of the ‘branch I strain’, which is more severe and lethal and has been diagnosed outside the African continent, is increasing. Meanwhile, a new, more lethal and more transmissible variant of ‘branch Ib’ has been spreading in the Democratic Republic of the Congo since last September. The striking feature of this outbreak is that women and children under 15 years of age are the most affected. Data show that more than 70 percent of all reported infections are among patients under 15 years of age, and among deaths, the figure is as high as 85 percent. Particularly noteworthy is the fact that the mortality rate among children is four times higher than among adults. What is the risk of spreading monkeypox? The risk of transnational transmission of monkeypox virus may increase due to the peak travelling season and frequent international contacts. However, the monkeypox virus is mainly transmitted through prolonged close contact, such as sexual intercourse, skin-to-skin contact and...
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  • DEEPBLUE Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent was awarded CE 1434 Certificate

    News Oct 11, 2021

    DEEPBLUE Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent was awarded CE 1434 Certificate
    On October 8, 2021, the novel coronavirus (COVID-19) neutralizing antibody (double antigen sandwich) detection reagent (colloidal gold method) independently developed by Anhui Deepblue Medical successfully obtained the CE1434 certificate, which meets the relevant EU requirements and market standards. Entry qualification. CE 1434 self-test certification is not only difficult, long-term, and strict, but also a test of comprehensive strength. In July 2021, DeepBlue Medical's novel coronavirus (COVID-19) antigen detection reagent obtained the CE1434 certificate, and the new coronavirus (COVID-19) neutralizing antibody (double-antigen sandwich) detection reagent obtained the CE1434 certificate. The strong recognition of the research and development technology of viral in vitro diagnostic reagents has far-reaching significance for the development of the international market and brand expansion. The novel coronavirus (COVID-19) neutralizing antibody (double-antigen sandwich) detection reagent independently developed by Anhui Deepblue Medical has obtained the CE1434 certificate, which can not only be freely sold in the 31 EU member states, but also bring more convenience to the global anti-epidemic. Check resources. The blessing of the CE1434 certificate also reflects the European market's recognition of the performance and user experience of DeepBlue Medical products, and it is also a high affirmation of the comprehensive strength of DeepBlue Medical. At present, most countries and regions in the world have gradually shifted from nucleic acid testing during the outbreak to neutralizing antibody testing to assess whether immunity is protected. The Deepblue Medical Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent can simply, quickly and effectively reflect the presence and level of neutralizing antibodies after vaccination, and play a guiding role in the need for booster vaccination. In the future, Deepblue Medical will continue to adhere to the vision of "based on the health industry, give full play to the advantages of science and technology, and build a health industry aircraft carrier", strive to develop better products, and contribute to the global epidemic prevention and control and the evaluation of the immune effect of vaccines!
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  • DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK

    News Dec 06, 2022

    DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK
    On December 1st, 2022, DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK, and was approved to be listed in the UK as an antigen saliva self-test product. The certificate is valid for 5 years. DEEPBLUE Medical is the first enterprise in China to obtain saliva self-test CTDA. With rich industry experience and professional independent research and development ability, DEEPBLUE Medical actively expands overseas registration while deeply studying international industry regulations, product certification regulations and commercial systems of various countries. At present, a series of products independently developed and produced by DEEPBLUE Medical have successively participated in the bidding activities of governments all over the world, and have been listed and sold in hospitals, supermarkets and pharmacies in several overseas countries, thus establishing a stable and reliable regional network, and making more DEEPBLUE Medical products go global. The successful achievement of CTDA certification of saliva product, an antigen self-test reagent in COVID-19, will help DEEPBLUE Medical to further expand overseas product sales channels and enhance the influence of its own brand, creating favorable conditions and laying a solid foundation for more independent brand products to enter the international market in the future. DEEPBLUE Medical will take this certification as an opportunity to further improve the quality of professional products, enhance the comprehensive strength of DEEPBLUE Medical with high-level international technical means, and provide strong support for the development of POCT industry.
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  • Statement

    News Oct 21, 2022

  • DEEPBLUE COVID-19 Antigen Test can detect Omicron variants  Evaluated by UCK Poland

    News Jun 08, 2022

    DEEPBLUE COVID-19 Antigen Test can detect Omicron variants Evaluated by UCK Poland
    DEEPBLUE COVID-19 Antigen Test can detect Omicron variants  Evaluated by UCK Poland Screenshot of the evaluation report Since the launch of the COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold), we have closely followed market changes and needs, and have always paid attention to the feedback of users and distributors after the product has been launched, and continuouslyvalidate our test with new variants. Recently we have completed the Clinical Evaluation on UCK Poland and the results indicates DEEPBLUE Antigen test is able to detect Omicron variants and the sensitivity is very high. Screenshot of the evaluation report
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  • DEEPBLUE's Monkeypox Test Kit have been registered in Germany and UK.

    News Oct 24, 2022

    DEEPBLUE's Monkeypox Test Kit have been registered in Germany and UK.
    The four products of Monkeypox Virus Antigen Test Kit (Colloidal Gold), Monkeypox Virus IgG/IgM Antibody Test kit (Colloidal Gold), Monkeypox Virus Nucleic Acid Test Kit (Isothermal Amplification- Real-time Fluorescence) and Monkeypox Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe) self-developed by DEEPBLUE Medical have passed the registration in Germany and UK. DEEPBLUE Medical, established in February 2010, is a national high-tech enterprise focusing on the R&D, production and marketing of in vitro diagnostic reagentsIt has been awarded the honors of Anhui Export Brand Demonstration Enterprise, Anhui Trademark Brand Demonstration Enterprise, Hefei Brand Cultivation Enterprise, Hefei Specialized and New Enterprise, Hefei Enterprise Technology Center, Hefei Harmonious Labor Relations Demonstration Enterprise, and High-tech Zone Three-Eight Red Flag Collective, etc. DEEPBLUE Medical has obtained CE 0123, CE 1434 and UK MHRA certifications for many products; 118 registrations have been obtained in many countries; virus test products have passed clinical validation in Germany PEI, Spain, Poland UCK, Denmark, the United States and other countries, with product footprints in Europe, North America, South America, the Middle East, Southeast Asia and nearly 100 countries around the world. DEEPBLUE Medical will continue to pay attention to international public health events, uphold the mission of "customer satisfaction is our highest honor, employee satisfaction is our eternal goal, shareholder satisfaction is our greatest responsibility", is committed to play the role of rapid diagnostic products in disease surveillance, health warning, and constantly increase investment in research and develop more directional test products to contribute to the promotion of high-quality development of the IVD industry. Popular Science Monkeypox is a zoonotic virulent disease caused by monkeypox virus (MPXV). It is a double-stranded DNA virus belonging to the genus orthopoxvirus of the family Poxviridae, along with smallpox virus, vaccinia virus and cowpox virus. In the past 4 months, the monkeypox epidemic has spread to 105 countries and regions. WHO data show that as of September 19, 2022, countries have reported 61,753 laboratory-confirmed cases and 533 suspected cases, including 23 deaths.
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  • DEEPBLUE COVID-19 antigen detection kit

    News Mar 15, 2021

    DEEPBLUE COVID-19 antigen detection kit "appears" on German TV
    The novel coronavirus antigen detection kit independently developed by Anhui Deep Blue Medical Technology Co., Ltd. passed the 3B stage test of the British government in 2020, and successfully obtained the British MHRA registration certificate. Good news came from Germany in 2021. At the beginning of March, the novel coronavirus antigen detection kit passed the evaluation of the German laboratory PEI. German TV stations simultaneously explained the steps of using the dark blue antigen detection kit to the public in detail, no laboratory equipment or professional Laboratory personnel or medical personnel operate. After obtaining special permission from Germany, the public can take samples and test at home. The results will be obtained within 15-20 minutes, and the test results will be used to determine whether they are infected with the new coronavirus. The Deepblue Novel Coronavirus Antigen Detection Kit is simple to operate, fast to detect, and easy to sample. Both front nasal swabs and saliva can be detected. Report link: https://v.qq.com/x/page/x3233f39lbk.html
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