Anbio Biotechnology Limited · 89-08 · CHINA

For Anbio Biotechnology Limited · 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 Rapid COVID-19 Antigen Test (Colloidal Gold) | COVID-19 IgM/IgG Antibody Colloidal Gold Test | Rapid COVID-19 Antigen Test (Colloidal Gold) | Rapid COVID-19 Antigen Test (Colloidal Gold); 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 - - MN COVID-19 Multi-Analyte Antigen Device; date published is 05/04/2021; address is No.2016, Wengjiao West Road, Xinyang Street, Haicang District, , Xiamen, Fujian CHINA, verified against its source on 2026-09-16.

What the source says

Anbio Biotechnology Limited Date Published : 05/04/2021 No.2016, Wengjiao West Road, Xinyang Street, Haicang District, , Xiamen, Fujian CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 02/10/2023 Desc: Rapid COVID-19 Antigen Test (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 05/04/2021 Desc: COVID-19 IgM/IgG Antibody Colloidal Gold Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: Rapid COVID-19 Antigen Test (Colloidal Gold) 83 Q - - MN COVID-19 Multi-Analyte Antigen Device Date Published: 02/10/2023 Desc: Rapid COVID-19 Antigen Test (Colloidal Gold)

— 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.