# Aesku Group GmbH & Co. KG · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Aesku Group GmbH & Co. KG · 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 AESKULISA? SARS-CoV-2 NP IgM | AESKULISA SARS-CoV-2 S1 IgG | AESKULISA SARS-CoV-2 S1 IgM | AESKULISA SARS-CoV-2 NP IgG; 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 2026-09-16.

- **Firm:** Aesku Group GmbH & Co. KG _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY _(verified: appears in the quote below)_
- **Date published:** 01/29/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** AESKULISA? SARS-CoV-2 NP IgM | AESKULISA SARS-CoV-2 S1 IgG | AESKULISA SARS-CoV-2 S1 IgM | AESKULISA SARS-CoV-2 NP IgG _(verified: each item appears in the quote below)_

## What the source says

> Aesku Group GmbH & Co. KG Date Published : 01/29/2021 Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY 83 Q - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: AESKULISA? SARS-CoV-2 NP IgM 83 Q - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: AESKULISA SARS-CoV-2 S1 IgG 83 Q - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: AESKULISA SARS-CoV-2 S1 IgM 83 Q - - KO Reagent, coronavirus serological Date Published: 01/29/2021 Desc: AESKULISA SARS-CoV-2 NP IgG

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).