BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    AESKU.DIAGNOSTICS GmbH&Co.KG

    Reg #: 3003825930 · FEI: 3003825930 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    16

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    Registration Details

    Registration Name
    AESKU.DIAGNOSTICS GmbH&Co.KG
    Registration Number
    3003825930
    FEI Number
    3003825930
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MIKROFORUM RING 2
    City
    WENDELSHEIM Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K172461

    Owner / Operator

    Firm Name
    Aesku.Diagnostics GmbH & Co. KG
    Operator Number
    9057973
    Address
    MIKROFORUM RING 2, --
    City
    WENDELSHEIM
    State
    Rhineland-Palatinate
    Postal Code
    55234
    Country
    DE

    US Agent

    Business Name
    Bion Enterprises, Ltd.
    Contact Name
    Nadine Shabat
    Address
    455 State Street, Suite 100
    City
    Des Plaines
    State
    IL
    ZIP
    60016
    Country
    US
    Email
    [email protected]
    Phone
    847 5445044 ext. 2149

    Products

    Device Name Product Code
    Calculator/Data Processing Module, For Clinical Use JQP
    Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
    Anti-Dna Antibody, Antigen And Control LSW
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control DHN
    Extractable Antinuclear Antibody, Antigen And Control LLL
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Antinuclear Antibody, Antigen, Control LKJ
    Multi-Analyte Controls Unassayed OHQ
    Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) NBT
    Light, Microscope IBJ
    Station, Pipetting And Diluting, For Clinical Use JQW
    Antibodies, Gliadin MST
    System, Test, Anticardiolipin Immunological MID
    Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use PIV
    Autoantibodies, Endomysial(Tissue Transglutaminase) MVM
    System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) MSV

    Proprietary Names

    HERA (HER-1000) AESKUSLIDES® ANCA AESKULISA® PR3 AESKULISA dsDNA G AESKUSLIDES® nDNA (Crithidia luciliae) AESKULISA® snRNP-C AESKULISA® Cenp-B AESKULISA® Jo-1 AESKULISA® Sm AESKULISA® SS-B AESKULISA® ANA-8Pro AESKULISA® SS-A AESKULISA® ENA-6Pro AESKULISA® Scl-70 AESKULISA® U1-70 AESKULISA ANA HEp-2 AESQC® ANA HEp-2 Nucleolar AESQC® ANA HEp-2 Cytoplasmic AESQC® ANA HEp-2 Homogeneous AESQC® ANA HEp-2 Speckled AESQC® Pool 1 AESQC® ANA HEp-2 Panel 1 AESQC® ANA HEp-2 Centromere AESQC® Pool 5 AESQC® Pool 3 AESQC® IFA Negative Control AESQC® Pool 4 AESQC® Pool 2 AESQC® Pool Mix AESKULISA® ASCA LED's HELMED® AUTOMATED IFA PROCESSOR (HEL-1000) AESKULISA® DGP AESKULISA® Cardiolipin AESKULISA® Glia AESKUSLIDES ® ANA HEp-2-Gamma HELIOS® AUTOMATED IFA SYSTEM (IOS-1000) AESKULISA® MPO AESKULISA® tTg New Gen AESKULISA® beta2-Glyco AESKULISA® ENA-6S AESKUSLIDES® ANA-HEp-2

    Establishment Types

    Manufacture Medical Device