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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liofilchem MIC Test Strip

    DI: 08055182873821 · Model: Doxycycline DXT 0.016-256 · LIOFILCHEM SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Liofilchem MIC Test Strip
    Primary DI
    08055182873821
    Version / Model
    Doxycycline DXT 0.016-256
    Catalog Number
    $92156-01
    Company Name
    LIOFILCHEM SRL
    Labeler DUNS
    435342134
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-12
    Public Version
    1
    Public Version Date
    2019-09-20
    Public Version Status
    New
    Public Device Record Key
    8f42c2f3-ffba-477c-91a2-322115eac48e

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

    GMDN Terms

    Code Name
    37300 Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

    Identifiers

    Type ID
    Package 28055182873825
    Primary 08055182873821
    Package 18055182873828

    Premarket Submissions

    Submission Number Supplement Number
    K190914 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius