# BIOTEKE CORPORATION (WUXI) CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For BIOTEKE CORPORATION (WUXI) 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 2019-nCoV Antigen Test Kit (colloidal gold method); product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is 4th Floor , D5 No.1719,Huishan Avenue , Wuxi City, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** BIOTEKE CORPORATION (WUXI) 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:** 4th Floor , D5 No.1719,Huishan Avenue , Wuxi City, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** 2019-nCoV Antigen Test Kit (colloidal gold method) _(verified: appears in the quote below)_

## What the source says

> BIOTEKE CORPORATION (WUXI) CO., LTD Date Published : 07/27/2021 4th Floor , D5 No.1719,Huishan Avenue , Wuxi City, Jiangsu CHINA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: 2019-nCoV Antigen Test Kit (colloidal gold method)

## 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/).