Newscen Coast Bio-Pharmaceutical Co · 89-08 · CHINA
For Newscen Coast Bio-Pharmaceutical Co · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.