# Seegene Inc. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Seegene Inc. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) | Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y); product code is 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 12/03/2021; address is Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Seegene Inc. _(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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/03/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: each item appears in the quote below)_
- **Product:** Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) | Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y) _(verified: each item appears in the quote below)_

## What the source says

> Seegene Inc. Date Published : 12/03/2021 Taewonbilding , 7 F Taewon B/Dsongpa; 91 Ogeum-Ro , Songpa, Seoul KOREA (THE REPUBLIC OF) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/03/2021 Desc: Allplex SARS-CoV- 2/FluA/FluB/RSV Assay (Cat No. RV10260Y; RV10259X) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 12/03/2021 Desc: Allplex SARS-CoV- 2/Flu/RSV Assay (Cat No. RV10274X; RV10277Y)

## 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/).