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510(k) Data Aggregation

    K Number
    K962609
    Device Name
    GRAM NEGATIVE IDENTIFICATION PLUS CARD
    Manufacturer
    BIOMERIEUX VITEK, INC.
    Date Cleared
    1996-08-30

    (58 days)

    Product Code
    LRH
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    LRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified. In addition to the organisms currently claimed with the GNI Card, the GNI+ Card has added the following 13 new organism claims: - Aeromanas veronii biovar veronii Budvicia aquatica Burkholdenia mallei CDC Group EO-2 Chromobacterium violaceum Edwardsiella hoshinae Klebsiella ornithinolytica Moellerella wisconsensis Rahnella aquatilis Shigella boydii/flexneri Sphingobacterium spiritivorum Sphingobacterium thalpophilum Yokenella regensburgei (Koserella trabulsii)
    Device Description
    The GNI+ Card consists of a plastic card with thirty wells that contain 28 dehydrated biochemical broths, one negative control broth and one growth control broth. The broths are re-hydrated with a saline suspension of a pure culture isolated from a patient specimen. The GNI+ Card performs a variety of conventional and non-conventional biochemical tests that are based on established biochemical methods. Organism identification usually requires between 2-12 hours of incubation on the automated Vitek System.
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    K Number
    K961042
    Device Name
    MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
    Manufacturer
    DADE MICROSCAN, INC.
    Date Cleared
    1996-05-30

    (77 days)

    Product Code
    LRH
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    LRH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rapid identification of non-fastidious aerobic and facultatively anacrobic gram-negative bacilli from human clinical specimens
    Device Description
    Not Found
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