# Assure Tech (Hangzhou) Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Assure Tech (Hangzhou) 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 Rapid Response COVID-19 Antigen Rapid Test Device; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** Assure Tech (Hangzhou) Co., Ltd _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** Rapid Response COVID-19 Antigen Rapid Test Device _(verified: appears in the quote below)_

## What the source says

> Assure Tech (Hangzhou) Co., Ltd Date Published : 06/22/2021 Nd-5th Floor, Building 4 1418 , 50 Moganshan Road; Gongshu , Hangzhou, Zhejiang CHINA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Rapid Response COVID-19 Antigen Rapid Test Device

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).