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510(k) Data Aggregation

    K Number
    K060998
    Device Name
    QMS TOBRAMYCIN
    Manufacturer
    SERADYN, INC.
    Date Cleared
    2006-07-21

    (101 days)

    Product Code
    LCR
    Regulation Number
    862.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERADYN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
    Device Description
    The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.
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    K Number
    K981496
    Device Name
    COLOR-SLIDE RF
    Manufacturer
    SERADYN, INC.
    Date Cleared
    1998-06-15

    (49 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERADYN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. The test provides results for one of the seven criteria used in the diagnosis of rheumatoid arthritis as suggested by the American College of Rheumatology
    Device Description
    ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum.
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    K Number
    K952544
    Device Name
    COLORSLIDER RUBELLA
    Manufacturer
    SERADYN, INC.
    Date Cleared
    1996-01-17

    (229 days)

    Product Code
    LQN
    Regulation Number
    866.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    SERADYN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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