Institut Virion/Serion Gmbh · 89-08 · GERMANY
For Institut Virion/Serion Gmbh, import alert is 89-08; country is GERMANY; 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 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 2026-09-30.
- 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
— 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html