# SURE BIO-TECH (HONG KONG) CO LIMITED · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** SURE BIO-TECH (HONG KONG) CO LIMITED _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** 15/F, Room 1502 , Easey Commercial Building; 253-261 Hennessy Road , Wan Chai, Hong Kong Island HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 07/07/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** API Covid-Rapid IgM/IgG Antibody Test Kit | API Covid-Rapid IgM/IgG Antibody Test Kit | API Covid-Rapid IgM/IgG Antibody Test Kit _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).