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510(k) Data Aggregation

    K Number
    K200308
    Device Name
    MTS Lefamulin 0.016- 256 µg/mL
    Date Cleared
    2020-04-06

    (60 days)

    Product Code
    Regulation Number
    866.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Liofilchem s. r. 1.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MTS (MC Test Strip) Lefamulin 0.016 - 256 µg/mL is a quanttative method intended for the in vitro determination of animicrobal susceptbility 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 (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Lefamilin at concentrations of 0.016 - 256 ug/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation. Lefamulin has been shown to be active both clinically and in viro against these bacterial species according to the FDA drug approved label: Gram-positive bacteria Streptococcus pneumoniae Staphylococcus aureus (methicillin-susceptible isolates) Gram-Negative bacteria Haemophilus influenzae
    Device Description
    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 (MC) in ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
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