BEUDAMED
    2 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Completed × Clear all

    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

    FDA Enforcement
    Class I ·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021

    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

    FDA Enforcement
    Class I ·Completed·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD·June 9, 2021