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510(k) Data Aggregation

    K Number
    K002024
    Device Name
    PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
    Manufacturer
    PANBIO, INC.
    Date Cleared
    2000-11-22

    (142 days)

    Product Code
    GRY
    Regulation Number
    866.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970189
    Device Name
    FIF TM
    Manufacturer
    PANBIO, INC.
    Date Cleared
    1997-05-21

    (120 days)

    Product Code
    KQJ, GIS
    Regulation Number
    864.7340
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.
    Device Description
    The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution. The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.
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    K Number
    K962176
    Device Name
    TPP
    Manufacturer
    PANBIO, INC.
    Date Cleared
    1996-10-18

    (135 days)

    Product Code
    MIF
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABS, Inc. TpP™ EIA is an enzyme linked immunoassay for the quantitative determination of soluble fibrin polymers in human plasma. It is indicated as an aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy.
    Device Description
    The TpP™ EIA employs a murine monoclonal antibody (MAb), specific for soluble fibrin polymer, as a capture antibody immobilized on a microtiter plate (MTP). This MAb recognizes a conformational epitope present only on the TpP™ entities but which is absent from fibrinogen and degradation products of fibrin and fibrinogen. During the first incubation phase TpP™ in human plasma specimens bind to the capture antibody. Afterwards the plate is rinsed, and a conjugate, another murine monoclonal antibody, labeled with horseradish peroxidase (HRP) is added to the well. This peroxidase conjugated MAb binds to a separate site on the TpP™ molecule during a second incubation period. Excess enzyme conjugated MAb is washed out and a subsequent application and incubation with tetramethylbenzidine (TMB) substrate follows. The reaction after TMB incubation is terminated with dilute sulfuric acid. The level of the TpP™ present in the specimen sample is determined colorimetrically from the enzymatic activity of detection MAb conjugate. The intensity of the color is proportional to the concentration of TpP™. Calibrator standard is provided with the kit.
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