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510(k) Data Aggregation

    K Number
    K143592
    Device Name
    GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
    Date Cleared
    2015-04-16

    (119 days)

    Product Code
    Regulation Number
    866.3045
    Why did this record match?
    Product Code :

    NVQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors. Use of this assay is limited to designated laboratory Response Network (LRN) and Department of Defense (D0D).
    Device Description
    The gamma phage is a lytic bacteriophage which binds to specific cell-surface components of susceptible bacteria. Their DNA is injected into the bacterium. The gamma phage replicate within the bacterium and produce PlyG lysine (2), resulting in lysis of the infected cell and release of phage. The release of newly synthesized phage leads to another round of phage infection and lysis. Materials Supplied: - Bacillus anthracis Gamma Phage Suspension, 0.5 ml - . Positive Control, Bacillus anthracis Pasteur Strain Spore Suspension, 1.0 ml - Negative Control, Bacillus cereus Spore Suspension, 1.0 ml ● Materials required but not supplied: - . 5% Sheep Blood Agar plate - . Inoculating loops, 1ul and 10 ul - Aerosol resistant pipette tips - . Disinfectant Equipment required: - Pipettor, 5-50 µ1 - Incubator, 35+/- 2 °C - Biological Safety Cabinet, Class II - Refrigerator, 2-8 ℃ .
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    K Number
    K051794
    Device Name
    GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
    Date Cleared
    2005-08-16

    (46 days)

    Product Code
    Regulation Number
    866.3045
    Why did this record match?
    Product Code :

    NVQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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