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510(k) Data Aggregation

    K Number
    K170127
    Manufacturer
    Date Cleared
    2017-03-14

    (60 days)

    Product Code
    Regulation Number
    866.1620
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Use of HardyDisk™ Ceftolozane/Tazobactam, (30/10µg) – C/T40, for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Ceftolozane/Tazobactam.

    The concentration of Ceftolozane/Tazobactam, (30/10µg) – C/T40, has been shown to be active against susceptible isolates of the following microorganisms with in vitro use: Citrobacter koseri, Morganil, Proteus vulgaris, Providencia rettgeri. Providencia stuartii, Serratia liquefaciens, and Serratia marcescens.

    The concentration of Ceftolozane/Tazobactam, (30/10µg) – C/T40, has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.

    HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing authorization letter for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Therefore, I cannot extract the requested information.

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