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

For GENOMICTREE · 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 StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | SARS-CoV-2 Real-TM | AccuraDTect SARS-CoV-2 RT-qPCR Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/29/2022; address is 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** GENOMICTREE _(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:** 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/29/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: each item appears in the quote below)_
- **Product:** StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) | SARS-CoV-2 Real-TM | AccuraDTect SARS-CoV-2 RT-qPCR Kit _(verified: each item appears in the quote below)_

## What the source says

> GENOMICTREE Date Published : 11/29/2022 44-6 Techno 10-Ro , Daejon , Yuseong, Daejeon Gwangyeogsi KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: StrongStep Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (Product code QJR) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: SARS-CoV-2 Real-TM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/29/2022 Desc: AccuraDTect SARS-CoV-2 RT-qPCR 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/).