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510(k) Data Aggregation

    K Number
    K160070
    Device Name
    Rheumatoid Factor (RF) Kit for use on SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2016-12-07

    (329 days)

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

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rheumatoid Factor (RF) Kit for use on SPAPLUS is intended for the quantitative in vitro measurement of rheumatoid factors in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K140396
    Device Name
    FREELITE HUMAN LAMBDA FREE KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2014-04-16

    (57 days)

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

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The kit is intended for the quantitation of lambda free light chains in serum and urine on Binding Site SPAPLUS. Measurement of free light chains in serum aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis, light chain deposition dissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. Measurement of free light chains in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinaemia, AL amyloidosis and light chain deposition with other laboratory and clinical findings.
    Device Description
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    K Number
    K140664
    Device Name
    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2014-04-16

    (29 days)

    Product Code
    DEB
    Regulation Number
    866.5620
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is designed for the quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K123256
    Device Name
    HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-07-03

    (258 days)

    Product Code
    DEM
    Regulation Number
    866.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Human α1-antitrypsin Kit for use on SPAPLUs is designed for the quantitative in vitro determination of a1-antitrypsin in human serum using the SPAPLus turbidimetric analyzer. The measurement of a1- antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, a1- antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K121045
    Device Name
    HUMAN ALBUMIN CSF KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-06-19

    (439 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Human Albumin CSF Kit for use on SPAPLUS is intended for the in-vitro quantification of human albumin in serum and cerebrospinal fluid (CSF) samples on the SPAPLUS analyser. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K122965
    Device Name
    HUMAN CAERULOPLASMIN KIT
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-06-03

    (252 days)

    Product Code
    DDB
    Regulation Number
    866.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K120901
    Device Name
    HUMAN IGA CSF KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-05-30

    (430 days)

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

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human IgA in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunoglobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.
    Device Description
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    K Number
    K122304
    Device Name
    HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2013-04-15

    (257 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Human C1 Inactivator kit for use on SPAPLUS is intended for the in vitro measurement of human C1 inactivator in human serum using the SPAPLUS Analyzer. Measurement of C1 inactivator levels in serum is an aid in the diagnosis of hereditary angioedema (HAE) in conjunction with other laboratory and clinical findings.
    Device Description
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    K Number
    K100179
    Device Name
    SPAPLUS
    Manufacturer
    THE BINDING SITE GROUP, LTD.
    Date Cleared
    2010-08-13

    (204 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE BINDING SITE GROUP, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative in vitro determination of human C3c in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings.
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