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    K Number
    K024079
    Device Name
    ALIBI BIOLOGICAL INDICATOR, MODEL WS
    Manufacturer
    ARDEN LABORATORIES, INCORPORATED
    Date Cleared
    2003-02-27

    (79 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARDEN LABORATORIES, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.
    Device Description
    ALIBI is a biological indicator that complies with the USP XXV:2002 monograph Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. The ALIBI biological indicator consists of a paper carrier inoculated with of Bacillus subtilis var. niger ATCC 9372 bacterial endospores, and a primary package made of glassine. After exposure to an ethylene oxide sterilization cycle, the biological indicator is incubated in soybean casein digest broth at 30-35°C for 7 days. Growth of biological indicator spores is evidenced by the presence of turbidity in the growth medium. If the sterilization cycle killed all of the biological indicator spores, the growth medium remains clear.
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