Reference Source

Ustar Biotechnologies (Hangzhou · 89-08 · CHINA

For Ustar Biotechnologies (Hangzhou · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Ustar Biotechnologies (Hangzhou Date Published : 01/06/2022 New Century Tower Fl 8 , 3766 Nanhuan Rd , Hangzhou, Zhejiang CHINA 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

accessdata.fda.gov, retrieved 2026-09-15

Source

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