DNA LINK, INC · 89-08 · KOREA (THE REPUBLIC OF)
For DNA LINK, 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 AccuFind COVID19 IgG; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 12/28/2020; address is 2f Cluster Center , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- DNA LINK, 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
- 2f Cluster Center , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/28/2020 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- AccuFind COVID19 IgG verified
What the source says
DNA LINK, INC Date Published : 12/28/2020 2f Cluster Center , Seoul, 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 - - KO Reagent, coronavirus serological Date Published: 12/28/2020 Desc: AccuFind COVID19 IgG
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.