Wuhan UNScience Biotechnology Co Ltd · 89-08 · CHINA
For Wuhan UNScience Biotechnology 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 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 2026-09-30.
- 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
— 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: 01/26/2021 Desc: Novel Coronavirus COVID-19 IgM/IgG Test Kit (Colloidal Gold)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html