Hangzhou Genesis Biodetection & Biocontrol Co., LTD. · 89-08 · CHINA
For Hangzhou Genesis Biodetection & Biocontrol 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 KaiBiLi COVID-19 Antigen Rapid Test Device | AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 08/31/2021; address is Hangzhou Economic , No. 139 10th Street (East); Technology Development Zone , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- Hangzhou Genesis Biodetection & Biocontrol 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
- Hangzhou Economic , No. 139 10th Street (East); Technology Development Zone , Hangzhou, Zhejiang CHINA verified
- Date published
- 08/31/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- KaiBiLi COVID-19 Antigen Rapid Test Device | AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test each item verified
What the source says
Hangzhou Genesis Biodetection & Biocontrol Co., LTD. Date Published : 08/31/2021 Hangzhou Economic , No. 139 10th Street (East); Technology Development Zone , Hangzhou, Zhejiang CHINA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 08/31/2021 Desc: KaiBiLi COVID-19 Antigen Rapid Test Device 83 Q - - KP Coronavirus antigen detection test system. Date Published: 08/31/2021 Desc: AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html