# JIANGSU COWIN BIOTECH CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For JIANGSU COWIN BIOTECH 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 SARS-CoV-2 & Influenza A/B Nucleic Acid Test; product code is 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 12/07/2021; address is East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA, verified against its source on 2026-09-16.

- **Firm:** JIANGSU COWIN BIOTECH 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:** East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA _(verified: appears in the quote below)_
- **Date published:** 12/07/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: appears in the quote below)_
- **Product:** SARS-CoV-2 & Influenza A/B Nucleic Acid Test _(verified: appears in the quote below)_

## What the source says

> JIANGSU COWIN BIOTECH CO LTD Date Published : 12/07/2021 East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/07/2021 Desc: SARS-CoV-2 & Influenza A/B Nucleic Acid Test

## 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/).