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

For Humasis 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 SARS-CoV-2 IgG/IgM Antibody Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Humasis 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:** Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/20/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** SARS-CoV-2 IgG/IgM Antibody Test _(verified: appears in the quote below)_

## What the source says

> Humasis Co Ltd Date Published : 04/20/2022 Rm.114,502,504,604-1,B03-01,B03-02,88 , Jeonpa-Ro,Dongan-Gu , Anyang-Si, GYEONGGIDO KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: SARS-CoV-2 IgG/IgM Antibody Test

## 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/).