Lepu Medical Technology (Beijing) Co., Ltd.
Lepu Medical Technology (Beijing) Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Lepu Medical Technology (Beijing) Co., Ltd.
FDA recalls by Lepu Medical Technology (Beijing) Co., Ltd.
- Z-1620-2021 — 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).
- Z-1619-2021 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Lepu Medical Technology (Beijing) Co., Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.