Reference Source

SHENZHEN LVSHIYUAN BIOTECHNOLOGY · 89-08 · CHINA

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
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
Address
Building No.2 D , Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist , Shenzhen, Dongguan CHINA verified
Date published
10/21/2020 verified
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 each item verified
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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

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