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

For Boditech Med, 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 Ichroma COVID-19 Ab (with ichroma II analyzer) | ExAmplar COVID-19 real-time PCR kit (L) | Ichroma COVID-19 Ab (with ichroma II analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) | AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/19/2020; address is 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Boditech Med, 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:** 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 10/19/2020 _(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 - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices _(verified: each item appears in the quote below)_
- **Product:** Ichroma COVID-19 Ab (with ichroma II analyzer) | ExAmplar COVID-19 real-time PCR kit (L) | Ichroma COVID-19 Ab (with ichroma II analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) | AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) | Ichroma COVID-19 Ab (with ichroma II analyzer) _(verified: each item appears in the quote below)_

## What the source says

> Boditech Med, Inc. Date Published : 10/19/2020 43 Geodudanji1-Gil , Dongnae-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 09/07/2021 Desc: ExAmplar COVID-19 real-time PCR kit (L) 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: AFIAS COVID-19 Ag (with AFIAS- 6 Analyzer) 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Ichroma COVID-19 Ab (with ichroma II analyzer)

## 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/).