Aesku Group GmbH & Co. KG · 89-08 · GERMANY

For Aesku Group GmbH & Co. KG, 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 AESKULISA SARS-CoV-2 S1 IgM | AESKULISA SARS-CoV-2 S1 IgG | AESKULISA SARS-CoV-2 NP IgG | AESKULISA? SARS-CoV-2 NP IgM; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/29/2021; address is Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY, verified against its source on 2026-09-30.

What the source says

Aesku Group GmbH & Co. KG Date Published : 01/29/2021 Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.