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

For DXGEN CORP · 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 EDGC RapidCheck COVID-19 IgG Test Kit | Epithod 616 COVID-19 IgG Test Kit and EDGC RapidCheck COVID-19 IgG Test Kit; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is 303 1 Hanlim Huma , Gunpo Si, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** DXGEN CORP _(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:** 303 1 Hanlim Huma , Gunpo Si, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 03/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** EDGC RapidCheck COVID-19 IgG Test Kit | Epithod 616 COVID-19 IgG Test Kit and EDGC RapidCheck COVID-19 IgG Test Kit _(verified: each item appears in the quote below)_

## What the source says

> DXGEN CORP Date Published : 03/11/2021 303 1 Hanlim Huma , Gunpo Si, KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: EDGC RapidCheck COVID-19 IgG Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 03/11/2021 Desc: Epithod 616 COVID-19 IgG Test Kit and EDGC RapidCheck COVID-19 IgG Test 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/).