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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARK™ Voriconazole II Calibrator

    DI: 00858724003230 · Model: 5030-0002-01 · ARK DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARK™ Voriconazole II Calibrator
    Primary DI
    00858724003230
    Version / Model
    5030-0002-01
    Catalog Number
    5030-0002-01
    Company Name
    ARK DIAGNOSTICS INC
    Labeler DUNS
    164880598
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    ab1ca939-a966-4b55-9919-5f64f4ec3987

    Device Description

    ARK™ Voriconazole II Calibrator is intended for use in calibration of the ARK™ Voriconazole II Assay

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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

    GMDN Terms

    Code Name
    55314 Voriconazole therapeutic drug monitoring IVD, calibrator

    Identifiers

    Type ID
    Primary 00858724003230

    Customer Contacts

    Phone
    5102706270
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius