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510(k) Data Aggregation

    K Number
    K020706
    Device Name
    EBV-VCA IGG ELISA TEST, MODEL EBG-100
    Manufacturer
    Date Cleared
    2002-06-13

    (101 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    GNP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Epstein Barr Virus Viral Capsid Antigen (EBV-VCA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV-VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV-VCA IgG ELISA should be used in conjunction with other EBV serologies.
    Device Description
    The EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-VCA antigen in human serum.
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    K Number
    K020707
    Device Name
    EBV-EBNA IGG ELISA KIT, MODEL EBG-100
    Manufacturer
    Date Cleared
    2002-06-13

    (101 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    GNP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.
    Device Description
    The EBV-EBNA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum.
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    K Number
    K020717
    Device Name
    EBV V VCA IGM ELISA KIT MODEL# EBM-200
    Manufacturer
    Date Cleared
    2002-06-13

    (100 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    GNP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV VCA IgM ELISA should be used in conjunction with other EBV serology.
    Device Description
    The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum.
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    K Number
    K981829
    Device Name
    IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
    Manufacturer
    Date Cleared
    1999-02-16

    (270 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    GNP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EBNA-1 IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EBNA-1 IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
    Device Description
    The CEBV-EBNA-1 IgG ELISA Kit is an enzyme-linked inımunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Nuclear antigen-1 in human serum.
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    K Number
    K981831
    Device Name
    IS EBV-EA-D IGG ELISA TEST SYSTEM
    Manufacturer
    Date Cleared
    1999-02-16

    (270 days)

    Product Code
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    GNP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EA-D IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EA-D IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
    Device Description
    The Is-EBV-EA-D IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Early Antigen diffuse in human serum. Recombinant EA-D antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-EA-D IgG antibodies, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating, Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to EA-D present in the sample.
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