Zhuhai Encode Medical Engineering Co., Ltd · 89-08 · CHINA
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
- 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
- Address
- No 20 Honghui Road , Xiaolinzhen , Zhuhai, Guangdong CHINA verified
- Date published
- 06/22/2020 verified
- 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. each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html