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

For Absology Co., Ltd. · 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 Absoludy COVID-19 IgM/IgG Combo | Absoludy COVID-19 IgM/IgG Rapid | INIST COVID-19 IgM/IgG Rapid; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Absology 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/26/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** Absoludy COVID-19 IgM/IgG Combo | Absoludy COVID-19 IgM/IgG Rapid | INIST COVID-19 IgM/IgG Rapid _(verified: each item appears in the quote below)_

## What the source says

> Absology Co., Ltd. Date Published : 01/26/2021 Simin-Daero 383, Dongan , # 1303 Digital Empire "B" , Anyang, Gyeonggi KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Absoludy COVID-19 IgM/IgG Combo 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: Absoludy COVID-19 IgM/IgG Rapid 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: INIST COVID-19 IgM/IgG Rapid

## 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/).