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510(k) Data Aggregation

    K Number
    K090920
    Device Name
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2009-12-30

    (273 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083289
    Device Name
    HUMAN BETA-2 MICROGLOBULIN KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2009-05-06

    (180 days)

    Product Code
    JZG
    Regulation Number
    866.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K082129
    Device Name
    HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2009-02-10

    (196 days)

    Product Code
    CFN, JIT, JJX
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
    Device Description
    Not Found
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    K Number
    K081827
    Device Name
    HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2008-12-19

    (175 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPIJS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
    Device Description
    Human IgA liquid reagent kit for use on SPAPLUS™
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    K Number
    K081674
    Device Name
    BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2008-10-15

    (120 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.
    Device Description
    Not Found
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    K Number
    K080384
    Device Name
    HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2008-06-06

    (114 days)

    Product Code
    NDY
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.
    Device Description
    Human Cystatin C kit For Use on the Modular P
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    K Number
    K072889
    Device Name
    HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2008-02-01

    (114 days)

    Product Code
    CFN
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070900
    Device Name
    FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2007-11-30

    (242 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitation of kappa free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. For the quantitation of lambda free light chains in serum on the Roche COBAS INTEGRA 400 and 400plus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K062372
    Device Name
    FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2007-06-21

    (311 days)

    Product Code
    DFH, DEH
    Regulation Number
    866.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K062183
    Device Name
    FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2006-11-21

    (113 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.
    Device Description
    Not Found
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