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

For WIZBIOSOLUTIONS · 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 iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is A-802 Woolim Lions Valley 2 , Sagimakgol-ro, 45beon-gil 14, Jungwon-gu , Seongnam, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** WIZBIOSOLUTIONS _(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:** A-802 Woolim Lions Valley 2 , Sagimakgol-ro, 45beon-gil 14, Jungwon-gu , Seongnam, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 11/24/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva _(verified: appears in the quote below)_

## What the source says

> WIZBIOSOLUTIONS Date Published : 11/24/2021 A-802 Woolim Lions Valley 2 , Sagimakgol-ro, 45beon-gil 14, Jungwon-gu , Seongnam, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva

## 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/).