Hangzhou Clongene Biotech Co., Ltd. · 89-08 · CHINA

For Hangzhou Clongene Biotech 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 Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | CLUNGENE SARSCOV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette | CLUNGENE COVID-19 IgG/IgM Rapid Test Kit | Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette; 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 listed twice: 09/02/2020 and 06/23/2020; address is No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-30.

What the source says

Hangzhou Clongene Biotech Co., Ltd. Date Published : 09/02/2020 No. 1 Yuchang Road , Yuhang , 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

The same source also states

Hangzhou Clongene Biotech Co., Ltd. Date Published : 06/23/2020 No. 1 Yuchang Road , Yuhang , Hangzhou, Zhejiang CHINA

— 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.