Tianjin New Bay Bioresearch Co., Ltd. · 89-08 · CHINA
For Tianjin New Bay Bioresearch 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 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 2026-09-30.
- Firm
- Tianjin New Bay Bioresearch 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
- Jian 3 , She Road; Ba Li Tai Industry Area Jinnan District , Tianjin, Tianjin CHINA verified
- Date published
- 04/29/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- QuikPac II Covid-19 IgG & IgM Test verified
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
— 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 - - KO Reagent, coronavirus serological Date Published: 04/29/2021 Desc: QuikPac II Covid-19 IgG & IgM Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html