# Tianjin New Bay Bioresearch Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Tianjin New Bay Bioresearch 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 QuikPac II Covid-19 IgG & IgM Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/29/2021; address is Jian 3 , She Road; Ba Li Tai Industry Area Jinnan District , Tianjin, Tianjin CHINA, verified against its source on 2026-09-16.

- **Firm:** Tianjin New Bay Bioresearch 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:** Jian 3 , She Road; Ba Li Tai Industry Area Jinnan District , Tianjin, Tianjin CHINA _(verified: appears in the quote below)_
- **Date published:** 04/29/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** QuikPac II Covid-19 IgG & IgM Test _(verified: appears in the quote below)_

## What the source says

> Tianjin New Bay Bioresearch Co., Ltd. Date Published : 04/29/2021 Jian 3 , She Road; Ba Li Tai Industry Area Jinnan District , Tianjin, Tianjin CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/29/2021 Desc: QuikPac II Covid-19 IgG & IgM 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/).