YD Diagnostics · 89-08 · KOREA (THE REPUBLIC OF)
For YD Diagnostics, 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 MolecuTech Real- Time COVID-19; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is 76, Seori-ro, Idong-eup, Cheoin-gu , Yongin-Si, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- YD Diagnostics 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
- 76, Seori-ro, Idong-eup, Cheoin-gu , Yongin-Si, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- MolecuTech Real- Time COVID-19 verified
What the source says
YD Diagnostics Date Published : 06/08/2022 76, Seori-ro, Idong-eup, Cheoin-gu , Yongin-Si, Gyeonggi 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 - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/08/2022 Desc: MolecuTech Real- Time COVID-19
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html