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510(k) Data Aggregation

    K Number
    K100455
    Device Name
    SPAPLUS ANALYZER
    Manufacturer
    THE BINDING SITE
    Date Cleared
    2010-09-03

    (198 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This kit is intended for the quantitative in vitro determination of human C4 in serum using the Binding Site SPAPLUS™ turbidimetric analyser. This test should be used in conjunction with other laboratory and clinical findings
    Device Description
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    K Number
    K012359
    Device Name
    TINA-QUANT COMPLEMENT C4 TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-11-29

    (127 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative immunological determination of human complement C4 in serum and plasma. Aid in detecting the presence and level of C4 found in autoimmune diseases, infections and inflammatory disorders.
    Device Description
    The Tina-quant Complement C4 Test System is based on the activation of the complement system which takes place via a classical and alternative route. Complement factor C4 participates in activation by the classical route. Human C4 forms a precipitate with a specific antiserum which is determined turbidimetrically.
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    K Number
    K010325
    Device Name
    WAKO AUTOKIT C4
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2001-06-25

    (143 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000468
    Device Name
    RANDOX COMPLEMENT C4
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-03-27

    (45 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994293
    Device Name
    DIMENSION C4 FLEX REAGENT CARTRIDGE
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2000-03-01

    (71 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
    Device Description
    The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.
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    K Number
    K981785
    Device Name
    C4 MININEPH ANTISERUM
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-20

    (579 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.
    Device Description
    Not Found
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    K Number
    K993481
    Device Name
    K-ASSAY C4
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-29

    (46 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum. Complement is a group of serum proteins which destroy cells by immunologically mediated lysis. Quantitative determination of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.
    Device Description
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    K Number
    K983356
    Device Name
    C4
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-11-04

    (41 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C4 assay is used for the quantitation of C4 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.
    Device Description
    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
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    K Number
    K964297
    Device Name
    N-ASSAY TIA C4 TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (258 days)

    Product Code
    DBI
    Regulation Number
    866.5240
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    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-4ssay TIA Test Kit is intended to be used for the quantitative determination of human (4 (4th complement component) in human serum by immunoturbidimetric assay. Cl4 aids in the diagnosing of immunological disorders, especially the entile with complement deficiency disorders, with complement deficiency disorders.
    Device Description
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    K Number
    K964300
    Device Name
    N-ASSAY TIA MULTI V-NL
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (258 days)

    Product Code
    DBI
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Multi V-NL Calibrator is intended to be used to calibrate the Crestat N-Assay TIA test Kits used To Carrorate the Orosas av C4 Test Kit, N-Assay Transferrin Test Kit, N-Assay Haptoglobin Test Kit, N-A66ay Alphael-Acid Glycoprotein Test Kit. The test kits are to be run on human serum.
    Device Description
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