# SURE BIO TECH · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SURE BIO TECH · 89-08 · CHINA, 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 CHINA; product is API Covid-Rapid IgM/IgG Antibody Test Kit | Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) | API Covid-Rapid IgM/IgG Antibody Test Kit | 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 2026-09-16.

- **Firm:** SURE BIO TECH _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** No.369 Hedong Road, Hi-Tech Industrial Development , Qingdao City Shandong, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 07/16/2020 _(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 - - KO Reagent, coronavirus serological | 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 | Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) | API Covid-Rapid IgM/IgG Antibody Test Kit | API Pharma Covid-Rapid IgM/IgG Antibody Test | API Covid-Rapid IgM/IgG Antibody Test Kit _(verified: each item appears in the quote below)_

## 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 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/16/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Covid-Rapid SARS-CoV-2 IgM/IgG AB (WB/S/P) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/16/2020 Desc: API Covid-Rapid IgM/IgG Antibody Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: API Pharma Covid-Rapid IgM/IgG Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/16/2020 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/).