Reference Source

Beijing Beier Bioengineering Co., LTD · 89-08 · CHINA

For Beijing Beier Bioengineering 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: 2019-New Coronavirus IgM/IgG Rapid Test Cassette (WB/S/P)

accessdata.fda.gov, retrieved 2026-09-15

Source

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