Hangzhou Genesis Biodetection & Biocontrol Co., LTD. · 89-08 · CHINA

For Hangzhou Genesis Biodetection & Biocontrol Co., LTD., import alert is 89-08; country is CHINA; 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)"; product is AntiCHEK SARS-CoV-2 (COVID-19) Rapid Antigen Test | KaiBiLi COVID-19 Antigen Rapid Test Device; 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 2026-09-30.

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

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.