Aesku.Diagnostics GmbH & Co. KG
US Last updated 24 May 2026
- Devices
- 97
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
AESKULISA® Glia-A 3501 Ref 3501
AESKUSLIDES nDNA (Crithidia luciliae) 53.100.US Ref 53.100.US
AESKULISA® snRNP-C 3105 Ref 3105
AESKULISA® Glia-A 30-7501US Ref 30-7501US
Aeskulisa® Ena-6S 7102US Ref 7102US
AESKULISA® Cardiolipin-Check 3202 Ref 3202
AESKULISA® ß2-Glyco-Check 30-7215US Ref 30-7215US
AESKULISA® Glia-G 30-7502US Ref 30-7502US
AESKULISA® PR3 sensitive 30-7302US Ref 30-7302US
Aeskulisa® Dgp-A 3513 Ref 3513
AESKULISA® ß2-Glyco-GM 30-7206US Ref 30-7206US
Aeskulisa® Ss-B 3110 Ref 3110
AESKULISA® ß2-Glyco-A 7205US Ref 7205US
Aeskulisa® Ss-B 7110US Ref 7110US
Aeskulisa® Mpo 30-7303US Ref 30-7303US
AESKULISA® Scl-70 3111 Ref 3111
AESKULISA® Cenp-B 7112US Ref 7112US
AESKUSLIDES ANCA Formalin 54.101.US Ref 54.101.US
Aeskulisa® Ena-6S 3102 Ref 3102
AESKULISA® Glia-A 7501US Ref 7501US
AESKULISA® ENA-6Pro 7103US Ref 7103US
AESKUSLIDES ANCA Ethanol 54.050.US Ref 54.050.US
AESKULISA® Jo-1 7113US Ref 7113US
Aeskulisa® Asca-A 7507US Ref 7507US
AESKULISA® Scl-70 7111US Ref 7111US
AESKULISA® DGP-Check 30-7515US Ref 30-7515US
Aeskulisa® Asca-G 30-7508US Ref 30-7508US
AESKUSLIDES® ANA-HEp-2 51.100 Ref 51.100
Aeskulisa® U1-70 7104US Ref 7104US
AESKULISA® Cenp-B 3112 Ref 3112
AESKULISA® DGP-Check 3515 Ref 3515
AESKULISA® Cardiolipin-GM 3204 Ref 3204
AESKULISA® ß2-Glyco-A 3205 Ref 3205
Aeskulisa® Asca-A 30-7507US Ref 30-7507US
AESKULISA® Jo-1 3113 Ref 3113
AESKULISA tTg-G New Generation 7504US Ref 7504US
AESKUSLIDES® nDNA (Crithidia luciliae) 53.120.US Ref 53.120.US
AESKULISA® ß2-Glyco-Check 3215 Ref 3215
AESKUSLIDES® ANA-HEp-2 51.100.US Ref 51.100.US
AESKULISA® dsDNA-G 7142US Ref 7142US
AESKULISA® ß2-Glyco-GM 3206 Ref 3206
AESKULISA tTg-A New Generation 30-7503US Ref 30-7503US
AESKULISA tTg-G New Generation 30-7504US Ref 30-7504US
AESKULISA® PR3 sensitive 3302 Ref 3302
HELIOS® Automated IFA System REF.IOS-1000.US Ref REF.IOS-1000.US
AESKULISA® ANA-HEp-2 3115 Ref 3115
Aeskulisa® Dgp-G 30-7514US Ref 30-7514US
Aeskulisa® Asca-G 7508US Ref 7508US
AESKULISA® ß2-Glyco-A 30-7205US Ref 30-7205US
Aeskulisa® Dgp-A 30-7513US Ref 30-7513US
Showing 1-50 of 97
FDA establishments
- AESKU.DIAGNOSTICS GmbH&Co.KG WENDELSHEIM Rhineland-Palatinate · DE FEI 3003825930
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.
Information
- Country
- US
- DUNS number
- 341714388