BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Liofilchem MTS (MIC Test Strip)

    DI: 08055182872893 · Model: Eravacycline ERV 0.002-32 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 MTS (MIC Test Strip)
    Primary DI
    08055182872893
    Version / Model
    Eravacycline ERV 0.002-32 µg/mL 1 STRIP
    Catalog Number
    92104-1
    Company Name
    LIOFILCHEM SRL
    Labeler DUNS
    435342134
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-09
    Public Version
    1
    Public Version Date
    2018-12-10
    Public Version Status
    New
    Public Device Record Key
    9147a066-4d07-4dd5-8dad-3683d8524ce3

    Device Description

    The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes

    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
    63218 Eravacycline minimum inhibitory concentration (MIC) IVD

    Identifiers

    Type ID
    Primary 08055182872893
    Package 28055182872897
    Package 18055182872890

    Premarket Submissions

    Submission Number Supplement Number
    K182557 000

    Storage Conditions

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