SHENZHEN LVSHIYUAN BIOTECHNOLOGY · 89-08 · CHINA

For SHENZHEN LVSHIYUAN BIOTECHNOLOGY, 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-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring COVID-19 IgG/IgM Rapid Test | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA, verified against its source on 2026-09-30.

What the source says

SHENZHEN LVSHIYUAN BIOTECHNOLOGY Date Published : 10/21/2020 Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA

— accessdata.fda.gov, retrieved 2026-09-22

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 2026-09-22

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.