# GENEONE DIAGNOSTIC CO LTD · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For GENEONE DIAGNOSTIC CO LTD · 89-08 · TAIWAN, 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 TAIWAN; product is GeneOne COVID-19 Nucleic Acid Diagnostic Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** GENEONE DIAGNOSTIC CO LTD _(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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN _(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:** GeneOne COVID-19 Nucleic Acid Diagnostic Kit _(verified: appears in the quote below)_

## What the source says

> GENEONE DIAGNOSTIC CO LTD Date Published : 06/08/2022 Xinyi Dist., Taipei City, 110 Taiwan (R.O.C.) , Rm. 2; 5f., No.51, Sec.2, Keelung Rd , Taipei City, TAIWAN 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: GeneOne COVID-19 Nucleic Acid Diagnostic Kit

## 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/).