# Zhuhai Encode Medical Engineering Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhuhai Encode Medical Engineering Co., Ltd · 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 Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device | Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device | Boston Bio EZ COVID-19 | SARS-CoV-2 IgG/IgM Rapid Test | Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device; product code is 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 - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is No 20 Honghui Road , Xiaolinzhen , Zhuhai, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhuhai Encode Medical Engineering Co., Ltd _(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 20 Honghui Road , Xiaolinzhen , Zhuhai, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2020 _(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 - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device | Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device | Boston Bio EZ COVID-19 | SARS-CoV-2 IgG/IgM Rapid Test | Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device _(verified: each item appears in the quote below)_

## What the source says

> Zhuhai Encode Medical Engineering Co., Ltd Date Published : 06/22/2020 No 20 Honghui Road , Xiaolinzhen , Zhuhai, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device 83 Q - - KO Reagent, coronavirus serological Date Published: 12/23/2020 Desc: Boston Bio EZ COVID-19 83 Q - - KO Reagent, coronavirus serological Date Published: 08/25/2021 Desc: SARS-CoV-2 IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device

## 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/).