# XIAMEN BAYSEN MEDI · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** XIAMEN BAYSEN MEDI _(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:** UNIT 401, NO 1 JINZHONG ROAD , HULI DISTRICT , Xiamen, CHINA _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(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 - - LW COVID-19 test home collection kit devices _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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

## 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/).