NDFOS CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
For NDFOS CO LTD, 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 ND COVID-19 IgG/IgM Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/11/2021; address is 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- NDFOS 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
- 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido KOREA (THE REPUBLIC OF) verified
- Date published
- 03/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- ND COVID-19 IgG/IgM Rapid Test verified
What the source says
NDFOS CO LTD Date Published : 03/11/2021 1-Dong 705-Ho, Innoplex Bldg. 306, Sinwon-Ro, Yeongtong-Gu , Suwon-Si, Gyeonggido 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: 03/11/2021 Desc: ND COVID-19 IgG/IgM Rapid Test
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html