BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liofilchem MTS (MIC Test Strip)

    DI: 08055182872879 · Model: PENICILLIN G P 0.002-32 µg/mL 10 Strip · 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
    08055182872879
    Version / Model
    PENICILLIN G P 0.002-32 µg/mL 10 Strip
    Catalog Number
    $92103-10
    Company Name
    LIOFILCHEM SRL
    Labeler DUNS
    435342134
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-10-26
    Public Version
    1
    Public Version Date
    2018-11-26
    Public Version Status
    New
    Public Device Record Key
    295823a8-4354-461c-a95b-7b0ef577a73f

    Device Description

    MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    42302 Penicillin G minimum inhibitory concentration (MIC) IVD

    Identifiers

    Type ID
    Package 18055182872876
    Primary 08055182872879
    Unit of Use 08055182872855

    Premarket Submissions

    Submission Number Supplement Number
    K181889 000

    Storage Conditions

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