4 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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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 Recall
Completed
·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Building 7-1
NO. 37 Chaoqian Rd; Changping Tech Zone
Beijing China·Product code QKP·April 26, 2021
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 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
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