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    Company News

    2026.02.02

    【Announcement】 Clongene's RSV Antigen Rapid Test Receives U.S. FDA 510(k) Clearance

    The respiratory syncytial virus (RSV) antigen detection kit independently developed by Hangzhou Clongene Biotech has obtained the 510(k) marketing approval from the US FDA.
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    2025.09.12

    Congratulations！CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup Receive FDA 510(k) Approval

    We are thrilled to announce that our CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup (17-Panel Drug Test) have obtained FDA 510(K) clearance! This innovative test is desi
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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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