DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. · 89-08 · CHINA

For DYNAMIKER BIOTECHNOLOGY (TIANJIN) 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 RapidCOV IgM/IgG Antibody Test | 2019-nCoV IgG/IgM Rapid Test | SARS-CoV-2 IgM/IgG Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin CHINA, verified against its source on 2026-09-30.

What the source says

DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. Date Published : 01/26/2021 No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin 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.