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    FDA UDI In Commercial Distribution 🇺🇸 United States

    IFA: Granulocytes (HCHO)

    DI: 04049016038801 · Model: FA 1201-1005 · EUROIMMUN Medizinische Labordiagnostika AG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IFA: Granulocytes (HCHO)
    Primary DI
    04049016038801
    Version / Model
    FA 1201-1005
    Company Name
    EUROIMMUN Medizinische Labordiagnostika AG
    Labeler DUNS
    322209263
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    657f6f3a-4226-4408-ad1e-d474bcc18507

    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 04049016038801

    Premarket Submissions

    Submission Number Supplement Number
    K051489 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius