LABGENOMICS CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
For LABGENOMICS CO LTD · 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 LabGun COVID-19 ExoFast RT-PCR Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 12/07/2021; address is 6f B-Wing Korea Bio Par , Seongnam-City, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- LABGENOMICS CO LTD 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
- 6f B-Wing Korea Bio Par , Seongnam-City, KOREA (THE REPUBLIC OF) verified
- Date published
- 12/07/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- LabGun COVID-19 ExoFast RT-PCR Kit verified
What the source says
LABGENOMICS CO LTD Date Published : 12/07/2021 6f B-Wing Korea Bio Par , Seongnam-City, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 12/07/2021 Desc: LabGun COVID-19 ExoFast RT-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.