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

For Z Biotech 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 RAPID TEST KIT | COVID-19 Ag RDT Test Kit | ANW COVID-19 Ag RDT Test Kit; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Z Biotech 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:** #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 07/27/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** RAPID TEST KIT | COVID-19 Ag RDT Test Kit | ANW COVID-19 Ag RDT Test Kit _(verified: each item appears in the quote below)_

## What the source says

> Z Biotech Inc. Date Published : 07/27/2021 #1409, 134, Gongdan-Ro , Heungdeok-Gu , Cheongju-Si, Chungcheongbuk-do KOREA (THE REPUBLIC OF) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: RAPID TEST KIT 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: COVID-19 Ag RDT Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: ANW COVID-19 Ag RDT 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/).