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510(k) Data Aggregation

    K Number
    K093604
    Device Name
    ETEST MOXIFLOXACIN 0.002-32 UG/ML
    Manufacturer
    Date Cleared
    2010-08-25

    (278 days)

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

    AB BIOMERIEUX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp. Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
    Device Description
    Not Found
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    K Number
    K082534
    Device Name
    ETEST VORICONAZOLE 0.002-32 UG/ML
    Manufacturer
    Date Cleared
    2009-11-02

    (426 days)

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

    AB BIOMERIEUX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This submission is for Etest Voriconazole for MIC determinations across 0.002-32 µg/mL with C. albicans, C. glabrata, C. parapsilosis and C. tropicalis. Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
    Device Description
    Etest is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.
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