GENBODY INC · 89-08 · KOREA (THE REPUBLIC OF)
For GENBODY 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 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 2026-09-30.
- 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)
— 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: 04/29/2021 Desc: COVID-19 IgM/IgG
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html