Suzhou Precigenome Ltd Co · 89-08 · CHINA (218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA)
For Suzhou Precigenome Ltd Co (218 Xinghu Street, A4-101, Biobay , Suzhou, Jiangsu CHINA), 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 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 2026-09-30.
- 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
— 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html