• List of COVID-19 Testing Kit Manufacturers in China

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    Virus Testing Kit Manufacturers in China

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    In this guide, we list 7 of the manufacturers that are currently approved by the China National Medical Products Administration (NMPA) to export COVID-19 testing kits. Note that, for each approved company, the NMPA also states which kind of testing kit the manufacturer can export, mainly nucleic acid and antibody testing kits. Note that you can download the full list of suppliers if you follow the link.

    Listed Companies

    • Shanghai ZJ Bio-Tech Co., Ltd.
    • Maccura Biotechnology Co., Ltd.
    • Beijing Applied Biological Technologies Co., Ltd.
    • Sansure Bio-tech Co., Ltd.
    • Wuhan Easydiagnosis Biomedicine Co., Ltd.
    • Zhuhai Livzon Diagnostics Inc.
    • Guangzhou Wondfo Bio-tech Co., Ltd

    Disclaimer

    We have selected the suppliers in this list based on their product scope and claimed certification. We don’t endorse any of the suppliers in this list, nor are we affiliated with them. We provide this supplier list as a free resource. Further, you should also contact your local authorities to confirm if there are any importing restrictions, testing or certification requirements in place. Keep in mind that virus testing kits, and other medical devices, are strictly regulated in most countries.

    Shanghai ZJ Bio-Tech Co., Ltd.

    ZJ Bio-Tech is a PCR-based molecular diagnostics solution manufacturer that provides services including diagnostics product development, and manufacturing. Their testing kits product covers infectious diseases, genetic disease, tumors, organ transplants, and the COVID-19.

    ZJ Bio-Tech offers two types of COVID-19 testing kits, which are the COVID-19 real-time RT-PCR kit and the COVID-19 real-time multiplex RT-PCR kit (detection for 3 genes).

    Both testing kits are compatible with medical instruments such as light cycler 2.0, PE 5700, ABI7000, MJ-chromo4, CFX 96, MH-opticon, single or multi-color systems and more.

    The company showcases several test reports for its testing kits, including Chinese, European and Australian certificates. The company claims to have been selling the COVID-19 test kits in more than 40 countries including Italy, Spain, Portugal, Germany, and others.

    COVID-19 Products

    • COVID-19 real-time RT-PCR kit
    • COVID-19 real-time multiplex RT-PCR kit (Detection for 3 genes)

    Certificates

    • NMPA
    • In-Vitro Diagnostic Medical Devices Directive (EU)
    • ISO 13485

    Company Information

    • Year of Registration: 2005
    • Locations: Shanghai, China, and California, US

    Address: Building No. 26, 588 Xinjunhuan Road, Shanghai, China

    Maccura Biotechnology Co., Ltd.

    Maccura Biotechnology was founded in 1994, as a manufacturer that focuses on clinical in-vitro diagnostic (IVD) products. They provide services for IVD products including product researching, manufacturing, and marketing.

    They claim to be ISO 13485, and ISO 14001 certified, and that many of their products are compliant with relevant CE directives.

    They offer two types of COVID-19 testing kits, the SARS-COV-2 nucleic acid detection kit (Fluorescent PCR) and SARS-COV-2 IgM/IgG antibody assay kit by the colloidal gold method.

    The simultaneous features of their testing kits have met the requirements of the World Health Organization (WHO), and they have added an internal control to prevent false-negative test results.

    Their COVID-19 testing kits use three different methods for the IVD test, which are Fluorescence PCR, CLIA, and Colloidal Gold Method. While the first is designed to detect nucleic acids, the last two are designed to detect antibodies.

    Further, importers can check with the laboratory requirements, instrument requirements, and product usage on their website.

    COVID-19 Products

    • SARS-COV-2 nucleic acid detection kit (Fluorescent PCR)
    • SARS-COV-2 IgM/IgG antibody assay kit by the colloidal gold method

    Certificates

    • NMPA
    • In-Vitro Diagnostic Medical Devices Directive (EU)
    • ISO 13485
    • ISO 14001

    Company Information

    • Year of Registration: 1994
    • Locations: More than 20 offices in China and the US

    Address: Room 102, 1st Floor, Eastside, Building 10, Yuquan Huigu, Tsinghua Science Park, 3# Minzhuang Road, Haidian Zone, Beijing, China

    Beijing Applied Biological Technologies Co., Ltd.

    Headquartered in Beijing, Applied Biological Technologies specializes in the development of detection solutions for pathogenic microbes. They have more than 300 types of PCR detection kits including the COVID-19 testing kits used in hospitals. They claim to be ISO 13485 certified and that some of their products are compliant with CE directives.

    Their own-developed COVID-19 nucleic acid detection kit was selected by the Beijing Municipal Science and Technology Commission. They offer both multiple real-time PCR testing kits for COVID19 and Quadruplex real-time PCR diagnostic kit for rapid COVID-19 detection.

    In addition, since the COVID outbreak in December 2019, Applied Biological Technologies cumulatively donated over 6.8 million RMB worth medical supplies including the testing kits to over 25 provinces in China, and over 65 districts in other countries.

    COVID-19 Products

    • Multiple real-time PCR testing kits for COVID19
    • Quadruplex real-time PCR diagnostic kit for rapid COVID-19 detection

    Certificates

    • NMPA
    • ISO 13485

    Company Information

    • Year of Registration: 2010
    • Locations: Changping, China

    Address: B-1st, Zhengdan International Building, No.33 Kexueyuan Road, Changping, Beijing, China

    Sansure Bio-tech Co., Ltd.

    Sansure Biotech was founded in 2008 and specializes in developing and manufacturing products for molecular laboratories. Their products include PCR diagnostic and research kits, fluorescence instruments and the COVID-19 diagnostic kits.

    For detecting COVID-19, they have developed a nucleic acid diagnostic kit using PCR-fluorescence. It features a one-tube fast test using magnetic beads that allows the separation and purification of cells and nucleic acids. The sample types can be either alveolar lavage fluid, throat swab, and sputum. Further, the sensitivity of the testing kit can reach 200 copies/ml.

    The company claims that their COVID-19 testing kits are compliant with the relevant CE Directive and approved by the NMPA. On their website, they provide a user manual regarding the COVID-19 testing kits.

    Importers can find more information about the testing kit that includes the test principle, intended use, diagnostic kit components, storage, stability, and testing instruction.

    COVID-19 Products

    • COVID-19 Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing)

    Certificates

    • NMPA
    • In-Vitro Diagnostic Medical Devices Directive (EU)

    Company Information

    • Year of Registration: 2008
    • Locations: Changsha, China

    Address: No.680, Lusong Road, Hi-Tech Development Zone, Yuelu District, Changsha, Hunan, China

    Wuhan Easydiagnosis Biomedicine Co., Ltd.

    Easydiagnosis Biomedicine is, according to their website, an ISO 13485 certified IVD manufacturer, and specializes in POCT rapid diagnostic reagents including the COVID-19 testing kits. Also, they claimed that their POCT rapid diagnostic products are registered with the FDA, and compliant with the CE directives.

    They offer a COVID-19 nucleic acid test kit intended for the qualitative detection of nucleic acid from SARS-CoV-2 in the upper and lower respiratory tract specimens. The testing kit is compatible with instruments such as ABI 7500, light cycler 480, and other fluorescence PCR platforms with FAM, HEX and ROX fluorescence detection channels.

    Also, they have developed the SARS-CoV-2 IgM/IgG antibody test kit, used for the qualitative detection of antibodies in human serum, plasma, and whole blood in vitro.

    COVID-19 Products

    • COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit
    • SARS-CoV-2 IgM/IgG Antibody Test Kit

    Certificates

    • NMPA
    • ISO 13485

    Company Information

    • Year of Registration: Not mentioned
    • Locations: Wuhan, China

    Address: 2nd Floor, Building E, Wuhan Overseas Scholar Business Park, No.1 Dongxin Road,

    Wuhan East Lake Hi-tech Development Zone, Wuhan, China

    Zhuhai Livzon Diagnostics Inc.

    Livzon Diagnostic was founded in 1989, as a subsidiary of Livzon Pharmaceutical Group Inc. and specializing in the development, production and marketing services for IVD products, including the COVID-19 antibody testing kit.

    Livzon Diagnostic claims to be ISO 13485, and ISO 9001 certified. Also, they claim that their COVID-19 antibody testing kits are compliant with the relevant CE directive.

    Their COVID-19 antibody testing kits are capable to test samples including serum, plasma, and venous whole blood. The testing kit can be used for single detection, separate detection of IgM and IgG, and it takes around 15 minutes to interpret the result.

    COVID-19 Products

    • Diagnostic Kit for IgM / IgG Antibody to COVID-19 (SARS-CoV-2)

    Certificates

    • NMPA
    • In-Vitro Diagnostic Medical Devices Directive (EU)
    • ISO 13485
    • ISO 9001

    Company Information

    • Year of Registration: 1989
    • Locations: Zhuhai, China

    Address: No.1, Pingdong No.3 Road, Nanping Science & Technology Industrial Park, Zhuhai, Guangdong, China

    Guangzhou Wondfo Bio-tech Co., Ltd

    Founded in 1992, Wondfo claims to be an ISO 9001 and ISO 13485 certified manufacture focusing on rapid diagnostics product development and production.

    They offer three different kinds of COVID-19 testing kits which are SARS-CoV-2 Real-time RT-PCR assay, SARS-CoV-2 Antibody test kit, and SARS-CoV-2 Antibody test kit (Lateral flow method). The SARS-CoV-2 real-time RT-PCR assay follows the guideline by the national health commission, and the other two testing kits can be used as an aid in the diagnosis of COVID-19.

    On their website, they provide the product manuals for each COVID-19 testing kit, therefore, Importers have access to the product specification and features before placing the order.

    COVID-19 Products

    • SARS-CoV-2 real-time RT-PCR assay
    • SARS-CoV-2 antibody test kit
    • SARS-CoV-2 antibody test kit(Lateral flow method)

    Certificates

    • NMPA
    • FDA
    • ISO 9001
    • ISO 13485

    Company Information

    • Year of Registration: 1992
    • Locations: Luogang, China

    Address: No.8 Lizhishan Road, Science City, Luogang District, Guangzhou, China

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