# SHENZHEN LVSHIYUAN BIOTECHNOLOGY · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHENZHEN LVSHIYUAN BIOTECHNOLOGY · 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 Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method; 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 - - 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 - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA, verified against its source on 2026-09-16.

- **Firm:** SHENZHEN LVSHIYUAN BIOTECHNOLOGY _(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:** Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA _(verified: appears in the quote below)_
- **Date published:** 10/21/2020 _(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 - - 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 - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: each item appears in the quote below)_
- **Product:** Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method | Green Spring COVID-19 IgG/IgM Rapid Test | Green Spring COVID-19 IgG/IgM Rapid Test | COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit | SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method _(verified: each item appears in the quote below)_

## What the source says

> SHENZHEN LVSHIYUAN BIOTECHNOLOGY Date Published : 10/21/2020 Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 03/23/2021 Desc: Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: Green Spring COVID-19 IgG/IgM Rapid Test 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Green Spring USA COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: Green Spring COVID-19 IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/02/2021 Desc: Green Spring SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: Green Spring COVID-19 IgG/IgM Rapid Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: Green Spring COVID-19 IgG/IgM Rapid Test 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: COVID-19 (2019-nCoV) Coronavirus IgG/IgM Rapid Test Kit 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: SARS CoV2-19 lgM/lgG Antibody Assay Kit by Colloidal Gold Method

## 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/).