# BIOSCIENCE(TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For BIOSCIENCE(TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD · 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 Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test | Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/23/2020; address is No.201.10 Siwei Road,Dongli District,Tianjin,China , No.14, International Medical Device Park, Liujing Road, Dongli Economic And Technology Development District , Tianjin, Tianjin CHINA, verified against its source on 2026-09-16.

- **Firm:** BIOSCIENCE(TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD _(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.201.10 Siwei Road,Dongli District,Tianjin,China , No.14, International Medical Device Park, Liujing Road, Dongli Economic And Technology Development District , Tianjin, Tianjin CHINA _(verified: appears in the quote below)_
- **Date published:** 06/23/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test | Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody _(verified: each item appears in the quote below)_

## What the source says

> BIOSCIENCE(TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD Date Published : 06/23/2020 No.201.10 Siwei Road,Dongli District,Tianjin,China , No.14, International Medical Device Park, Liujing Road, Dongli Economic And Technology Development District , Tianjin, Tianjin CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 09/30/2021 Desc: Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody

## 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/).