Beijing Beier Bioengineering Co., LTD · 89-08 · CHINA
For Beijing Beier Bioengineering 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-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P); product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/15/2021; address is No. 99 Chuangxin Road , Lucheng Industrial Development Zone Huangcun Town , Daxing, Beijing CHINA, verified against its source on 2026-09-30.
- Firm
- Beijing Beier Bioengineering 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
- No. 99 Chuangxin Road , Lucheng Industrial Development Zone Huangcun Town , Daxing, Beijing CHINA verified
- Date published
- 04/15/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P) verified
What the source says
Beijing Beier Bioengineering Co., LTD Date Published : 04/15/2021 No. 99 Chuangxin Road , Lucheng Industrial Development Zone Huangcun Town , Daxing, Beijing 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: 04/15/2021 Desc: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html