Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K980596
    Device Name
    VCA IGM ELISA TEST SYSTEM
    Manufacturer
    CLARK LABORATORIES, INC.
    Date Cleared
    1998-07-22

    (155 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLARK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Clark anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgG, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis in the adult population.
    Device Description
    The Wampole Epstein-Barr Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Wampole anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, EBNA-1 IgG, EA-D IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The VCA IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Viral Capsid antigen. Afinity purified gp125 VCA antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question
    K Number
    K980912
    Device Name
    VCA IGG ELISA TEST SYSTEM
    Manufacturer
    CLARK LABORATORIES, INC.
    Date Cleared
    1998-07-22

    (134 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLARK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis in a adult population.
    Device Description
    The Epstein-Barr Viral Capsid Antigen (VCA) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to VCA antigen. The Clark anti-VCA IgG assay may be used in conjunction with other Epstein-Barr serologies (EA-D IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The VCA IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Viral Capsid Antigen. Purified recombinant VCA antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question
    K Number
    K980598
    Device Name
    EBNA-1 IGM ELISA TEST SYSTEM
    Manufacturer
    CLARK LABORATORIES, INC.
    Date Cleared
    1998-05-01

    (73 days)

    Product Code
    LLM
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLARK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epstein Barr Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Clark anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis in adult populations.
    Device Description
    The Wampole Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to EBNA-1 antigen. The Wampole anti-EBNA-1 IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA-D IgG, EBNA-1 IgG and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgM is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question
    K Number
    K973123
    Device Name
    EA-D IGG ELISA TEST SYSTEM
    Manufacturer
    CLARK LABORATORIES, INC.
    Date Cleared
    1998-03-26

    (218 days)

    Product Code
    LSE
    Regulation Number
    866.3235
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLARK LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
    Device Description
    Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.
    Ask a Question

    Page 1 of 1