Suzhou Precigenome Ltd Co · 89-08 · CHINA
For Suzhou Precigenome Ltd Co · 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 FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is 218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA, verified against its source on 2026-09-16.
- Firm
- Suzhou Precigenome Ltd Co 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
- 218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR) verified
What the source says
Suzhou Precigenome Ltd Co Date Published : 06/08/2022 218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.