Reference Source

BIOSINO BIO-TECHNOLOGY · 89-08 · CHINA

For BIOSINO BIO-TECHNOLOGY · 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 SARS-CoV-2 Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/02/2021; address is 27 Chaoqian Rd , Bejing, CHINA, verified against its source on 2026-09-16.

Firm
BIOSINO BIO-TECHNOLOGY 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
27 Chaoqian Rd , Bejing, CHINA verified
Date published
03/02/2021 verified
Product code
83 Q - - KO Reagent, coronavirus serological verified
Product
SARS-CoV-2 Antibody Test verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

BIOSINO BIO-TECHNOLOGY Date Published : 03/02/2021 27 Chaoqian Rd , Bejing, CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: SARS-CoV-2 Antibody Test

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

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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