BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liofilchem MTS (MIC Test Strip)

    DI: 08055182872367 · Model: Plazomicin 0.016-256 µg/mL · LIOFILCHEM SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    Liofilchem MTS (MIC Test Strip)
    Primary DI
    08055182872367
    Version / Model
    Plazomicin 0.016-256 µg/mL
    Catalog Number
    $92070-10
    Company Name
    LIOFILCHEM SRL
    Labeler DUNS
    435342134
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-09-06
    Public Version
    1
    Public Version Date
    2018-10-08
    Public Version Status
    New
    Public Device Record Key
    361418a9-0803-4b4a-a557-badc18516d69

    Device Description

    The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens

    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
    63310 Plazomicin minimum inhibitory concentration (MIC) IVD

    Identifiers

    Type ID
    Primary 08055182872367
    Unit of Use 08055182872343
    Package 18055182872364

    Customer Contacts

    Phone
    +390858930745
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181708 000

    Storage Conditions

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