HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD · 89-08 · CHINA

For HANGZHOU TESTSEA BIOTECHNOLOGY 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 One Step SARS-CoV2(COVID-19) IgG/IgM Test | One Step SARS-CoV2(COVID-19) IgG/IgM Test | SARS-CoV-2 IgG/IgM Test Cassette | TESTSEALABS Covid-19 IgG/IgM Rapid Test Kit | One Step SARS-CoV2(COVID-19) IgG/IgM Test; 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 06/23/2020; address is Building 1 2nd Floor , Pingyaozhen Yuhang District , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-30.

What the source says

HANGZHOU TESTSEA BIOTECHNOLOGY CO LTD Date Published : 06/23/2020 Building 1 2nd Floor , Pingyaozhen Yuhang District , 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.