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Sign in to claim this brandAesku.Diagnostics GmbH & Co. KG
US
Last updated May 24, 2026
What Aesku.Diagnostics GmbH & Co. KG makes
Aesku.Diagnostics GmbH & Co. KG manufactures in vitro diagnostic (IVD) kits for autoimmune and connective tissue disease testing, including enzyme immunoassays (EIA) for coeliac disease-associated antibodies, anticardiolipin antibodies, antinuclear antibodies (ANA), and anti-neutrophil cytoplasmic antibodies (ANCA), as well as fluorescent immunoassays for ANA screening and ANCA detection. Specific products target tissue transglutaminase antibodies, anti-dsDNA antibodies, and B2-glycoprotein I complexes. The portfolio also includes fluorescent slides for ANA screening using Crithidia luciliae.
The company’s diagnostic kits are classified under FDA categories, with most falling into Class I and Class II regulatory classifications. These devices are listed via the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 341714388
Catalogue (97)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aeskulisa® U1-70 | 3104 | FDA UDI | Class II | Active |
| Aeskulisa® Mpo | 3303 | FDA UDI | Class II | Active |
| AESKULISA® dsDNA-G | 3142 | FDA UDI | Class II | Active |
| AESKULISA® ANA-8Pro | 3101 | EUDAMEDFDA UDI | Class II | Active |
| AESKUSLIDES® ANA-HEp-2 gamma | 51.181.US | FDA UDI | Class II | Active |
| AESKULISA® ANA-8Pro | 7101US | FDA UDI | Class II | Active |
| AESKULISA® Sm | 3106 | FDA UDI | Class II | Active |
| Aeskulisa® Asca-A | 3507 | FDA UDI | Class II | Active |
| AESKULISA® snRNP-C | 7105US | FDA UDI | Class II | Active |
| AESKUSLIDES ANCA Formalin | 54.051.US | FDA UDI | Class II | Unknown |
| AESKULISA® Cardiolipin-Check | 7202US | FDA UDI | Class II | Active |
| AESKULISA® ANA-HEp-2 | 7115US | FDA UDI | Class II | Active |
| Helios® Automated Ifa System | REF.IOS-1000 | FDA UDI | Class II | Unknown |
| AESKUSLIDES® ANA HEp-2-Gamma | 51.101.US.Bulk5 | FDA UDI | Class II | Active |
| AESKULISA® Glia-G | 7502US | FDA UDI | Class II | Active |
| AESKULISA® dsDNA-G | 30-7142US | FDA UDI | Class II | Active |
| AESKULISA® Cardiolipin-A | 7203US | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-GM | 7206US | FDA UDI | Class II | Active |
| AESKUSLIDES® ANA-HEp-2 gamma | 51.101.US | FDA UDI | Class II | Active |
| AESKULISA tTg-A New Generation | 7503US | FDA UDI | Class II | Active |
| Aeskulisa® Dgp-G | 3514 | FDA UDI | Class II | Active |
| AESKUSLIDES ANCA Ethanol | 54.100.US | FDA UDI | Class II | Active |
| AESKULISA® ANA-HEp-2 | 30-7115US | FDA UDI | Class II | Active |
| Aeskulisa® Ss-A | 3107 | FDA UDI | Class II | Active |
| AESKULISA® Sm | 7106US | FDA UDI | Class II | Active |
| AESKULISA® Cardiolipin-GM | 7204US | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-Check | 7215US | FDA UDI | Class II | Active |
| HELMED® Automated IFA Processor | REF.HEL-1000.US | FDA UDI | Class I | Active |
| AESKUSLIDES® ANA-HEp-2 gamma | 51.181.US.BULK5 | FDA UDI | Class II | Active |
| Aeskulisa® Asca-G | 3508 | FDA UDI | Class II | Active |
| Aeskulisa® Ss-A | 7107US | FDA UDI | Class II | Active |
| Hera | REF.HER-1000 | EUDAMEDFDA UDI | Class I | Active |
| AESKULISA® ENA-6Pro | 3103 | FDA UDI | Class II | Active |
| AESKULISA® Cardiolipin-A | 3203 | FDA UDI | Class II | Active |
| AESKULISA® Glia-G | 3502 | FDA UDI | Class II | Active |
| Helmed® Automated Ifa Processor | REF.HEL-1000 | EUDAMEDFDA UDI | Class I | Active |
| Aeskulisa Ds Dna G | K041628 | FDA 510(k) | Class II | Active |
| AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | K172348 | FDA 510(k) | Class II | Active |
| Aeskulisa Glia A And Aeskulisa Glia G | K052439 | FDA 510(k) | Class II | Active |
| Aesku Pr3 | K091859 | FDA 510(k) | Class II | Active |
| Aeskulisa Ena 6 S | K041753 | FDA 510(k) | Class II | Active |
| Modification To Aeskulisa Ds Dna G | K081251 | FDA 510(k) | Class II | Active |
| Aeskulisa Ana Hep-2, Ref 30-7115us | K081104 | FDA 510(k) | Class II | Active |
| Aeskulisa Mpo, Model 30-7303us | K091860 | FDA 510(k) | Class II | Active |
| Aeskulisa Dgp-A, Aeskulisa Dgp-G, Aeskulisa Dgp-Check | K132082 | FDA 510(k) | Class II | Active |
| Aeskuslides Ana Hep-2 | K120889 | FDA 510(k) | Class II | Active |
| AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | K172461 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- AESKU.DIAGNOSTICS GmbH&Co.KG WENDELSHEIM Rhineland-Palatinate · DE FEI 3003825930