# SUZHOU PRECIGENOME LTD, CO · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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 St Industria , Suzhou, CHINA, verified against its source on 2026-09-16.

- **Firm:** SUZHOU PRECIGENOME LTD, CO _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 218 Xinghu St Industria , Suzhou, CHINA _(verified: appears in the quote below)_
- **Date published:** 06/08/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** FastPlex Triplex SARS-CoV-2 Detection Kit (RT- PCR) _(verified: appears in the quote below)_

## What the source says

> SUZHOU PRECIGENOME LTD, CO Date Published : 06/08/2022 218 Xinghu St Industria , Suzhou, 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).