ZHUHAI KEYU BIOLOGICAL ENGINEERING · 89-08 · CHINA
For ZHUHAI KEYU BIOLOGICAL ENGINEERING · 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 ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid 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 - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is D Building F 2 , No. 288 Dong Bypass; Jinwan Districtr , Zhuhai, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- ZHUHAI KEYU BIOLOGICAL ENGINEERING 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
- D Building F 2 , No. 288 Dong Bypass; Jinwan Districtr , Zhuhai, Guangdong CHINA verified
- Date published
- 10/21/2020 verified
- 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 - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid Test | ProMed COVID-19 IgM/IgG Antibody Rapid Test each item verified
What the source says
ZHUHAI KEYU BIOLOGICAL ENGINEERING Date Published : 10/21/2020 D Building F 2 , No. 288 Dong Bypass; Jinwan Districtr , Zhuhai, Guangdong CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: ProMed COVID-19 IgM/IgG Antibody Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html