JIANGSU COWIN BIOTECH CO LTD · 89-08 · CHINA
For JIANGSU COWIN BIOTECH 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 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 2026-09-30.
- 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
What the source says
JIANGSU COWIN BIOTECH CO LTD Date Published : 12/07/2021 East Of Lujia Road , Pharmaceutical City Of , Taizhou, Jiangsu 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 - - 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html