BIOTEKE CORPORATION (WUXI) CO., LTD · 89-08 · CHINA
For BIOTEKE CORPORATION (WUXI) 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 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 2026-09-30.
- Firm
- BIOTEKE CORPORATION (WUXI) 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
- 4th Floor , D5 No.1719,Huishan Avenue , Wuxi City, Jiangsu CHINA verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- 2019-nCoV Antigen Test Kit (colloidal gold method) verified
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
— 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 - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: 2019-nCoV Antigen Test Kit (colloidal gold method)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html