Nantong Egens Biotechnology Co., Ltd. · 89-08 · CHINA
For Nantong Egens Biotechnology 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 EGENS COVID-19 IgG/IgM Rapid Test Kit | EGENS COVID-19 IgG/IgM Rapid Test Kit | EGENS COVID-19 IgG/IgM Rapid Test Kit; 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; date published is 06/22/2020; address is Building 15 , 1692 Xinghu Avenue , Nantong, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- Nantong Egens Biotechnology 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
- Building 15 , 1692 Xinghu Avenue , Nantong, Jiangsu 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 - - KP Coronavirus antigen detection test system. each item verified
- Product
- EGENS COVID-19 IgG/IgM Rapid Test Kit | EGENS COVID-19 IgG/IgM Rapid Test Kit | EGENS COVID-19 IgG/IgM Rapid Test Kit each item verified
What the source says
Nantong Egens Biotechnology Co., Ltd. Date Published : 06/22/2020 Building 15 , 1692 Xinghu Avenue , Nantong, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: EGENS COVID-19 IgG/IgM Rapid Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html