LIMING BIO-PRODUCTS CO., LTD. · 89-08 · CHINA
For LIMING BIO-PRODUCTS CO., LTD., import alert is 89-08; country is CHINA; 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)"; product is StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit | SARS-CoV-2 Real-TM | StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test | SARS-CoV2 Antigen Rapid Test | StrongStep System Device for 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 2026-09-30.
- 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
- StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | AccuraDTect SARS-CoV-2 RT-qPCR Kit | SARS-CoV-2 Real-TM | StrongStep SARS-CoV-2 lgM/IgG Antibody Rapid Test | SARS-CoV2 Antigen Rapid Test | StrongStep System Device for SARS-CoV2 Antigen Rapid Test each item verified
What the source says
LIMING BIO-PRODUCTS CO., LTD. Date Published : 05/28/2021 No. 12 Huayuan Road , Nanjing, Jiangsu CHINA
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: SARS-CoV-2 Real-TM 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: SARS-CoV2 Antigen 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html