DOWGENE DNA TESTING COMPANY · 89-08 · KOREA (THE REPUBLIC OF)
For DOWGENE DNA TESTING COMPANY · 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 Dow QuickFinder 2019-nCoV Real-Time PCR kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- DOWGENE DNA TESTING COMPANY 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
- Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- Dow QuickFinder 2019-nCoV Real-Time PCR kit verified
What the source says
DOWGENE DNA TESTING COMPANY Date Published : 06/08/2022 Rm 513 Ace High End Tow , Seoul, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: Dow QuickFinder 2019-nCoV Real-Time PCR kit
— 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.