BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AESKUSLIDES ANCA Ethanol

    DI: 04250289510370 · Model: 54.050.US · Aesku.Diagnostics GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AESKUSLIDES ANCA Ethanol
    Primary DI
    04250289510370
    Version / Model
    54.050.US
    Company Name
    Aesku.Diagnostics GmbH & Co. KG
    Labeler DUNS
    341714388
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-25
    Public Version
    2
    Public Version Date
    2018-07-06
    Public Version Status
    New
    Public Device Record Key
    811909fe-8faf-45d2-9f8b-9d6d4752ba48

    Device Description

    AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

    GMDN Terms

    Code Name
    55061 Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 04250289510370

    Premarket Submissions

    Submission Number Supplement Number
    K172461 000

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    2-8°C