SURE BIO-TECH (HONG KONG) CO LIMITED · 89-08 · HONG KONG SAR

For SURE BIO-TECH (HONG KONG) CO LIMITED · 89-08 · HONG KONG SAR, import alert is 89-08; 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)"; country is HONG KONG SAR; product is API Covid-Rapid IgM/IgG Antibody Test Kit | API Covid-Rapid IgM/IgG Antibody Test Kit | 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 - - KP Coronavirus antigen detection test system; date published is 07/07/2020; address is 15/F, Room 1502 , Easey Commercial Building; 253-261 Hennessy Road , Wan Chai, Hong Kong Island HONG KONG SAR, verified against its source on 2026-09-16.

What the source says

SURE BIO-TECH (HONG KONG) CO LIMITED Date Published : 07/07/2020 15/F, Room 1502 , Easey Commercial Building; 253-261 Hennessy Road , Wan Chai, Hong Kong Island HONG KONG SAR 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/07/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 07/07/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/07/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit

— accessdata.fda.gov, retrieved 2026-09-15

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.