Reference Source

JIANGSU COWIN BIOTECH CO LTD · 89-08 · CHINA

For JIANGSU COWIN BIOTECH 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 SARS-CoV-2 & Influenza A/B Nucleic Acid Test; product code is 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 12/07/2021; address is East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
JIANGSU COWIN BIOTECH 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
East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA verified
Date published
12/07/2021 verified
Product code
83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices verified
Product
SARS-CoV-2 & Influenza A/B Nucleic Acid Test verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

JIANGSU COWIN BIOTECH CO LTD Date Published : 12/07/2021 East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu CHINA 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/07/2021 Desc: SARS-CoV-2 & Influenza A/B Nucleic Acid Test

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

Source

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