# Singuway Biotech Inc. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Singuway Biotech Inc. · 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 COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Singuway COVID-19 Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/11/2021; address is Julongshan A Road , Pingshan District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Singuway Biotech Inc. _(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:** Julongshan A Road , Pingshan District , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 01/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** COVID-19 IgG/IgM Detection Kit (Colloidal Gold) | Singuway COVID-19 Test Kit _(verified: each item appears in the quote below)_

## What the source says

> Singuway Biotech Inc. Date Published : 01/11/2021 Julongshan A Road , Pingshan District , Shenzhen, Guangdong CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/11/2021 Desc: COVID-19 IgG/IgM Detection Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/11/2021 Desc: Singuway COVID-19 Test Kit

## 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/).