BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liofilchem MIC Test Strip (MTS)

    DI: 08055182870196 · Model: Ceftazidime 0.016-256 µg/mL 1 strip · LIOFILCHEM SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Liofilchem MIC Test Strip (MTS)
    Primary DI
    08055182870196
    Version / Model
    Ceftazidime 0.016-256 µg/mL 1 strip
    Catalog Number
    $92138-1
    Company Name
    LIOFILCHEM SRL
    Labeler DUNS
    435342134
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-06
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    38b6f9f6-7d11-448b-a5c5-9f88a2cad9c5

    Device Description

    MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime 0.016-256 are specialized strips impregnated with a predefined concentration gradient of Ceftazidime for susceptibility testing of Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgarism, Pseudomonas aeruginosa

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    43432 Ceftazidime minimum inhibitory concentration (MIC) IVD

    Identifiers

    Type ID
    Package 28055182870190
    Primary 08055182870196
    Package 18055182870193

    Customer Contacts

    Phone
    +390858930745
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K163298 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 8 Degrees Celsius