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510(k) Data Aggregation

    K Number
    K954923
    Device Name
    BACTEC FUNGAL MEDIUM
    Manufacturer
    BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
    Date Cleared
    1996-11-21

    (392 days)

    Product Code
    JTA
    Regulation Number
    866.2560
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    Product Code :

    JTA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Qualitative culture and recovery of yeasts and fungi from blood
    Device Description
    BACTEC Fungal Medium is a growth medium providing an aerobic environment for the detection of yeast and fungi. It has been designed for blood volumes of four to 10 mL, and is used specifically with BACTEC non-radiometric (NR) series instruments in the monitoring of clinical blood specimens for the presence of yeasts and fungi. BACTEC Fungal medium has a higher weight/volume concentration of dextrose and sucrose then the predicate device to enhance the recovery and CO2 production of yeast. Saponin was added to the BACTEC Fungal Medium as a lysing agent, and ferric ammonium citrate was added as a source of iron to stimulate recovery of fungi other than yeast. Resin was removed from this medium. Principles for detection of CO2 produced by microorganisms metabolizing blood culture medium nutrients are identical to the predicate device.
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