XIAMEN BAYSEN MEDI · 89-08 · CHINA

For XIAMEN BAYSEN MEDI · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; product is Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device | SARS-CoV-2 Antigen Rapid Test | COVID-19 Risk Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices; date published is 07/27/2021; address is UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA, verified against its source on 2026-09-16.

What the source says

XIAMEN BAYSEN MEDI Date Published : 07/27/2021 UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/27/2021 Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device 83 Q - - KO Reagent, coronavirus serological Date Published: 07/27/2021 Desc: Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 Rapid Test Device 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: SARS-CoV-2 Antigen Rapid Test 83 Q - - LW COVID-19 test home collection kit devices Date Published: 07/27/2021 Desc: COVID-19 Risk Test

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

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.