# LIMING BIO-PRODUCTS CO., LTD. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For LIMING BIO-PRODUCTS 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 SARS-CoV-2 Real-TM | StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit | StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test | StrongStep System Device for SARS-CoV2 Antigen Rapid Test | SARS-CoV2 Antigen Rapid Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 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 - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/28/2021; address is No. 12 Huayuan Road , Nanjing, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** LIMING BIO-PRODUCTS 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. 12 Huayuan Road , Nanjing, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(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 - - JR Reagents, 2019-novel coronavirus nucleic acid | 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:** SARS-CoV-2 Real-TM | StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit | StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test | StrongStep System Device for SARS-CoV2 Antigen Rapid Test | SARS-CoV2 Antigen Rapid Test _(verified: each item appears in the quote below)_

## What the source says

> LIMING BIO-PRODUCTS CO., LTD. Date Published : 05/28/2021 No. 12 Huayuan Road , Nanjing, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: SARS-CoV-2 Real-TM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: AccuraDTect SARS-CoV-2 RT-qPCR Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: StrongStep System Device for SARS-CoV2 Antigen Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: SARS-CoV2 Antigen Rapid Test

## 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/).