WIZBIOSOLUTIONS · 89-08 · KOREA (THE REPUBLIC OF)
For WIZBIOSOLUTIONS, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- Firm
- WIZBIOSOLUTIONS verified
- 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
- Address
- A-802 Woolim Lions Valley 2 , Sagimakgol-ro, 45beon-gil 14, Jungwon-gu , Seongnam, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- iCareDx PSS-1 RT- PCR Testing System for SARS-CoV-2 using saliva verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html