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510(k) Data Aggregation

    K Number
    K020689
    Device Name
    SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
    Manufacturer
    MIDI, INC.
    Date Cleared
    2002-10-31

    (241 days)

    Product Code
    NJO
    Regulation Number
    866.3370
    Why did this record match?
    Product Code :

    NJO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software. The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock® Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.
    Device Description
    The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
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