ERYIGIT MEDICAL DEVICES · 89-08 · TURKEY
For ERYIGIT MEDICAL DEVICES, import alert is 89-08; country is TURKEY; 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 Sentebiolab Senteligo SARS- CoV-2 (COVID-19) Multiplex qPCR Detection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 06/08/2022; address is Ivedik Osb 1453 Cad No , Yenimahalle, TURKEY, verified against its source on 2026-09-30.
- Firm
- ERYIGIT MEDICAL DEVICES 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
- TURKEY verified
- Address
- Ivedik Osb 1453 Cad No , Yenimahalle, TURKEY verified
- Date published
- 06/08/2022 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- Sentebiolab Senteligo SARS- CoV-2 (COVID-19) Multiplex qPCR Detection Kit verified
What the source says
ERYIGIT MEDICAL DEVICES Date Published : 06/08/2022 Ivedik Osb 1453 Cad No , Yenimahalle, TURKEY
— 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: Sentebiolab Senteligo SARS- CoV-2 (COVID-19) Multiplex qPCR Detection Kit
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html