GENBODY INC · 89-08 · KOREA (THE REPUBLIC OF)
For GENBODY INC · 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 COVID-19 IgM/IgG; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/29/2021; address is 3-18, 3-12, Eopseong 2-gil, , 3-18, Eopseong 2-gil, Seobuk-gu , Cheonan, Chungnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- GENBODY 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
- 3-18, 3-12, Eopseong 2-gil, , 3-18, Eopseong 2-gil, Seobuk-gu , Cheonan, Chungnam KOREA (THE REPUBLIC OF) verified
- Date published
- 04/29/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- COVID-19 IgM/IgG verified
What the source says
GENBODY INC Date Published : 04/29/2021 3-18, 3-12, Eopseong 2-gil, , 3-18, Eopseong 2-gil, Seobuk-gu , Cheonan, Chungnam KOREA (THE REPUBLIC OF) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/29/2021 Desc: COVID-19 IgM/IgG
— 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.