Aesku Group GmbH & Co. KG · 89-08 · GERMANY
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
- 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
- Mikro-Forum-Ring 2 , Wendelsheim, Rhineland-Palatinate GERMANY verified
- Date published
- 01/29/2021 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html