Ustar Biotechnologies (Hangzhou · 89-08 · CHINA
For Ustar Biotechnologies (Hangzhou, 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 EasyNAT Diagnostic Kit for Novel- Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 01/06/2022; address is New Century Tower Fl 8 , 3766 Nanhuan Rd , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-30.
- Firm
- Ustar Biotechnologies (Hangzhou 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
- New Century Tower Fl 8 , 3766 Nanhuan Rd , Hangzhou, Zhejiang CHINA verified
- Date published
- 01/06/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- EasyNAT Diagnostic Kit for Novel- Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay verified
What the source says
Ustar Biotechnologies (Hangzhou Date Published : 01/06/2022 New Century Tower Fl 8 , 3766 Nanhuan Rd , Hangzhou, Zhejiang 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 01/06/2022 Desc: EasyNAT Diagnostic Kit for Novel- Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html