Newscen Coast Bio-Pharmaceutical Co · 89-08 · CHINA
For Newscen Coast Bio-Pharmaceutical Co, 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 Mi.Sens SAA/CRP/IgM/IgG Cov-19 Microfluidic Rapid Test System | COVID-19 Microfluidic Combo Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 08/19/2021; address is No 65 6th Street, Teda , Tianjin, Tianjin CHINA, verified against its source on 2026-09-30.
- Firm
- Newscen Coast Bio-Pharmaceutical Co 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 65 6th Street, Teda , Tianjin, Tianjin CHINA verified
- Date published
- 08/19/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- Mi.Sens SAA/CRP/IgM/IgG Cov-19 Microfluidic Rapid Test System | COVID-19 Microfluidic Combo Test each item verified
What the source says
Newscen Coast Bio-Pharmaceutical Co Date Published : 08/19/2021 No 65 6th Street, Teda , Tianjin, Tianjin CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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 - - KO Reagent, coronavirus serological Date Published: 08/19/2021 Desc: Mi.Sens SAA/CRP/IgM/IgG Cov-19 Microfluidic Rapid Test System 83 Q - - KO Reagent, coronavirus serological Date Published: 08/19/2021 Desc: COVID-19 Microfluidic Combo Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html