BEUDAMED
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    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

    FDA Recall
    Completed ·Empowered Diagnostics LLC·Product code QKO·December 22, 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 Recall
    Completed ·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Building 7-1 NO. 37 Chaoqian Rd; Changping Tech Zone Beijing China·Product code QKO·April 26, 2021