Lepu Medical Technology (Beijing) Co., Ltd. · 89-08 · CHINA

For Lepu Medical Technology (Beijing) Co., Ltd., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Covid Test | SARS COV 2 Antigen Rapid Test | Corona Virus Test Kit | Corona Virus Reagent Kit | SARS COV2 Antibody Test Colloidal Gold Immunochromatography | SARS-COV-2 ANTIBODY TEST | Lepu Antigen Test; product code is 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 88 P - - PM General purpose reagent; date published is 05/28/2021; address is No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA, verified against its source on 2026-09-30.

What the source says

Lepu Medical Technology (Beijing) Co., Ltd. Date Published : 05/28/2021 No. 37 Chaoqian Rd. , Changping , Changping, Beijing CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.