# Anbio Biotechnology Limited · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** Anbio Biotechnology Limited _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "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:** CHINA _(verified: appears in the quote below)_
- **Address:** No.2016, Wengjiao West Road, Xinyang Street, Haicang District, , Xiamen, Fujian CHINA _(verified: appears in the quote below)_
- **Date published:** 05/04/2021 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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) _(verified: each item appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).