Reference Source

LIMING BIO-PRODUCTS CO., LTD. · 89-08 · CHINA

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
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
No. 12 Huayuan Road , Nanjing, Jiangsu CHINA verified
Date published
05/28/2021 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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
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 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

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

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

Source

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