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    2024.11.09

    Congratulations!Clongene Fentanyl Rapid Test Kit Receives FDA 510(k) Approval

    On November 8, 2024, Clongene independently developed the Fentanyl Rapid Test Kit, which received FDA 510(k) approval and can meet the testing needs of home and professional institutions. The product
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    2022.04.27

    Clungene COVID-19 Antigen Rapid Test Products Obtained TGA Certification in Australia

    “Clungene COVID-19 Antigen Rapid Test for self-testing” and “Clungene COVID-19 Antigen Rapid Test” manufactured by Clongene have obtained the TGA Certification in Australia on January 7, 2022. The cer
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    2022.04.27

    Clungene COVID-19 Antigen Rapid Test has obtained CE certification

    In February 2022, CLUNGENE® COVID-19 Antigen Rapid Test for self-testing manufactured by Clongene has obtained the CE certification in EU. Our self-testing product can be sold in the European Union an
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    2022.04.27

    CLUNGENE® COVID-19 Antigen Rapid Test Cassette Passed the PEI Test in Germany

    CLUNGENE® COVID-19 Antigen Rapid Test Cassette has passed the test of PEI in Germany. PEI (Paul-Ehrlich-Institut) is affiliated to the Federal Ministry of Health. It is the Cooperation Centre of WHO f
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    2022.08.18

    Congratulations! Clongene COVID-19 Antigen Rapid Tests have passed SARS-CoV-2 variants validation by TGA

    The TGA is reviewing all COVID-19-specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (AR
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