SURE BIO TECH · 89-08 · CHINA

For SURE BIO TECH, 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 API Covid-Rapid IgM/IgG Antibody Test Kit | API Covid-Rapid IgM/IgG Antibody Test Kit | Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) | API Pharma Covid-Rapid IgM/IgG Antibody Test | API Covid-Rapid IgM/IgG Antibody Test Kit; 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 07/16/2020; address is No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA, verified against its source on 2026-09-30.

What the source says

SURE BIO TECH Date Published : 07/16/2020 No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong 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.