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510(k) Data Aggregation

    K Number
    K112120
    Device Name
    DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2013-01-24

    (549 days)

    Product Code
    GHH, DAP, JIT
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D-Dimer Assay is for the quantitative determination of fibrin degradation products (D-Dimer) in human plasma. Measurement of D-Dimer is used as an aid in detecting the presence of intravascular coagulation and fibrinolysis. For in vitro diagnostic use only. The Diazyme D-Dimer Calibrator Set is intended for use of the calibration of the Diazyme D-Dimer Assay only. For in vitro diagnostic use only. The Diazyme D-Dimer Control Set is intended for use as quantitative quality controls for the Diazyme D-Dimer Assay only. For in vitro diagnostic use only.
    Device Description
    Diazyme's D-Dimer Assay is based on a latex enhanced immunoturbidimetric assay. D-Dimer proteins in the sample bind to the specific anti-D-Dimer antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of D-Dimer in the sample. The instrument calculates the D-Dimer concentration of a patient specimen by interpolation of the obtained signal of a 6-point calibration curve.
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    K Number
    K072288
    Device Name
    PATHFAST D-DIMER
    Manufacturer
    MITSUBISHI KAGAKU IATRON
    Date Cleared
    2009-05-06

    (629 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070453
    Device Name
    OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
    Manufacturer
    OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
    Date Cleared
    2007-06-11

    (115 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    System reagent for the quantitative determination of D-Dimer in human plasma on OLYMPUS analyzers. Aid in detecting the presence and degree of intravascular coagulation and fibrinolysis, and in monitoring therapy for disseminated intravascular coagulation.
    Device Description
    In this Olympus procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the D-Dimer of the patient serum and the anti-human D-Dimer antibodies coated on the latex particles
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    K Number
    K062203
    Device Name
    TINA-QUANT D-DIMER TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2007-03-14

    (225 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. In conjunction with a non-high clinical probability assessment, a normal (< 0.5 µg FEU/ml) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
    Device Description
    The Tina-Quant® D-Dimer test system is an immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers. Latex particles of uniform size are coated with monoclonal antibodies (F(ab')2 fragments) to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-dimer lead to an increase in the turbidity of the test reactants, which can be determined turbidimetrically. The calibrator is D-Dimer calibrator and the recommended control material is D-dimer Control I/II.
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    K Number
    K042890
    Device Name
    TRIAGE D-DIMER TEST, MODEL 98100
    Manufacturer
    BIOSITE INCORPORATED
    Date Cleared
    2004-11-29

    (41 days)

    Product Code
    GHH, DAP
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of crosslinked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
    Device Description
    The Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens.
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    K Number
    K030740
    Device Name
    MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2003-04-01

    (22 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidimetric assay for the in vitro quantitative determination of fibrin degradation products including D-Dimer and X-oligomers in plasma.
    Device Description
    The Tina-quant® D-Dimer Test system is a particle enhanced immunoturbidimetric assay. Latex particles are coated with monoclonal antibodies to the D-Dimer epitope. The antigen/antibody complexes produced by the addition of samples containing D-Dimer lead to an increase in turbidity.
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    K Number
    K021877
    Device Name
    MDA D-DIMER
    Manufacturer
    BIOMERIEUX, INC.
    Date Cleared
    2002-08-07

    (61 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quantitative determination of crosslinked fibrin degradation products containing the D-dimer domain in citrated human plasma. MDA D-Dimer is an assay for use in conjunction with a clinical Pre-test Probability Assessment (PTP) model in excluding deep vein thrombosis (DVT) in outpatients suspected of a first episode of DVT. MDA D-Dimer can also be used as and in the assessment and evaluation of patients suspected of pulmonary embolism (PE). The assay is designed for use on the MDA automated coagulation analyzers.
    Device Description
    bioMerieux Inc. MDA® D-Dimer is a homogeneous latex particle based immunoassay for the quatitative determination of cross-linked fibrin degradation products containing the D-dimer domain in citrated human plasma. These latex particles aggregate in the presence of fibrin derivatives containing the D-dimer domain. The rate of latex microparticle aggregation is proportional to the concentration of D-dimer in the sample. D-dimer concentration may be interpolated from a reference curve.
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    K Number
    K011143
    Device Name
    TINA-QUANT D-DIMER TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-05-29

    (46 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993276
    Device Name
    SIMPLIFY D-DIMER, MODEL DCGK1
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Date Cleared
    1999-12-14

    (75 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.
    Device Description
    The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.
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    K Number
    K972316
    Device Name
    OPUS D-DIMER
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1997-09-09

    (81 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Product Code :

    GHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.
    Device Description
    OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.
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