IONEBIO INC · 89-08 · KOREA (THE REPUBLIC OF)
For IONEBIO INC, 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 iLAMP Novel-CoV19 Detection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 12/07/2021; address is #1008-1012, Seongnam Central Biz Tower , 314, Galmachi-ro, Jungwon-gu , Seongnam-si, Gyeonggi-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- IONEBIO INC 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
- #1008-1012, Seongnam Central Biz Tower , 314, Galmachi-ro, Jungwon-gu , Seongnam-si, Gyeonggi-do KOREA (THE REPUBLIC OF) verified
- Date published
- 12/07/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- iLAMP Novel-CoV19 Detection Kit verified
What the source says
IONEBIO INC Date Published : 12/07/2021 #1008-1012, Seongnam Central Biz Tower , 314, Galmachi-ro, Jungwon-gu , Seongnam-si, Gyeonggi-do 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: 12/07/2021 Desc: iLAMP Novel-CoV19 Detection Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html