DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. · 89-08 · CHINA
For DYNAMIKER BIOTECHNOLOGY (TIANJIN) 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 2019-nCoV IgG/IgM Rapid Test | RapidCOV IgM/IgG Antibody Test | SARS-CoV-2 IgM/IgG Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin CHINA, verified against its source on 2026-09-16.
- Firm
- DYNAMIKER BIOTECHNOLOGY (TIANJIN) 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. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin CHINA verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- 2019-nCoV IgG/IgM Rapid Test | RapidCOV IgM/IgG Antibody Test | SARS-CoV-2 IgM/IgG Antibody Test each item verified
What the source says
DYNAMIKER BIOTECHNOLOGY (TIANJIN) CO., LTD. Date Published : 01/26/2021 No. 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Tianjin, Tianjin CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: 2019-nCoV IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: RapidCOV IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: SARS-CoV-2 IgM/IgG Antibody Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html