BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IFA: Granulocyte Mosaic 13

    DI: 04049016040163 · Model: FA 1201-1003-13 · EUROIMMUN Medizinische Labordiagnostika AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IFA: Granulocyte Mosaic 13
    Primary DI
    04049016040163
    Version / Model
    FA 1201-1003-13
    Company Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Labeler DUNS
    322209263
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2022-11-22
    Public Version Status
    Update
    Public Device Record Key
    91e7f974-c639-4959-9bc0-643b91e1d4e2
    Distribution End Date
    2022-05-27

    Device Characteristics

    Single Use
    Yes
    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 04049016040163

    Premarket Submissions

    Submission Number Supplement Number
    K051489 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius