Institut Virion/Serion Gmbh · 89-08 · GERMANY
For Institut Virion/Serion Gmbh · 89-08 · GERMANY, 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 GERMANY; product is SERION ELISA agile SARS-CoV-2 IgG | SERION ELISA agile SARS COV-2 IgA; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 08/30/2021; address is Friedrich-Bergius-Ring 19 , Wurzburg, Bavaria GERMANY, verified against its source on 2026-09-16.
- Firm
- Institut Virion/Serion Gmbh 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
- GERMANY verified
- Address
- Friedrich-Bergius-Ring 19 , Wurzburg, Bavaria GERMANY verified
- Date published
- 08/30/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- SERION ELISA agile SARS-CoV-2 IgG | SERION ELISA agile SARS COV-2 IgA each item verified
What the source says
Institut Virion/Serion Gmbh Date Published : 08/30/2021 Friedrich-Bergius-Ring 19 , Wurzburg, Bavaria GERMANY 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: SERION ELISA agile SARS-CoV-2 IgG 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: SERION ELISA agile SARS COV-2 IgA
— 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.