Wuhan UNScience Biotechnology Co Ltd · 89-08 · CHINA
For Wuhan UNScience Biotechnology 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 Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Building B18, 2nd Phase of Biomedical Park , #858 GaoXin Rd , Wuhan, Hubei CHINA, verified against its source on 2026-09-16.
- Firm
- Wuhan UNScience Biotechnology 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
- Building B18, 2nd Phase of Biomedical Park , #858 GaoXin Rd , Wuhan, Hubei CHINA verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold) verified
What the source says
Wuhan UNScience Biotechnology Co Ltd Date Published : 01/26/2021 Building B18, 2nd Phase of Biomedical Park , #858 GaoXin Rd , Wuhan, Hubei CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)
— 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.