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510(k) Data Aggregation

    K Number
    K233605
    Device Name
    ADVIA Centaur EBV-EBNA IgG
    Manufacturer
    Biokit S.A.
    Date Cleared
    2024-08-07

    (272 days)

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

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IqG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.
    Device Description
    Not Found
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    K Number
    K040120
    Device Name
    DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
    Manufacturer
    DIASORIN, INC.
    Date Cleared
    2005-04-29

    (465 days)

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

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DiaSorin LIAISON® EBNA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to EBV nuclear antigen synthetic peptide (EBNA) in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBNA IgG kit is used in conjunction with LIAISON® EBNA IgG immunoassay for quality control of assay runs. The LIAISON® EBV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBV IgM kit is used in conjunction with LIAISON® EBV IgM immunoassay for quality control of assay runs. The DiaSorin LIAISON® VCA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IqG antibodies to EBV viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control VCA IgG kit is used in conjunction with LIAISON® VCA IgG immunoassay for quality control of assay runs.
    Device Description
    The method for qualitative determination of specific IgG to EBNA is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBNA-1 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EBNA antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EBNA IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBNA IgG in calibrators, samples or controls. The method for qualitative determination of specific IgM to Epstein-Barr viral capsid antigens (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with p18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgM linked to an isoluminol derivative (isoluminolantibody conjugate). In the first step, samples and controls are diluted with Buffer A, which contains goat IgG to human IgG as an absorbent reagent to curb interference from human IgG specific to VCA or from rheumatoid factor. During the first incubation, VCA IgM antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgM already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured hy a photomultiplier as relative light units (RLU) and is indicative of the presence of VCA IgM in calibrators, samples or controls. The method for qualititative determination of specific IgG to EBV viral capsid antigen (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBV VCA p-18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, VCA IgG antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgG antibodies that are already bound to the solid phase. After each incubation, unbound material is removed Subsequently, the starter reagents are added and a flash with a wash cycle. chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBV VCA IgG antibodies present in calibrators, samples or controls.
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    K Number
    K984133
    Device Name
    THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-01-11

    (54 days)

    Product Code
    LLM, 83L
    Regulation Number
    866.3235
    Why did this record match?
    Product Code :

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This test system is designed for the manual or automated, qualitative detection of IgG antibodies to EBNA in human serum specimens. When used with other EBV serologies such as Heterophile, VCA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use.
    Device Description
    Not Found
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    K Number
    K973941
    Device Name
    IMMUNOWELL EBNA IGG TEST
    Manufacturer
    GenBio
    Date Cleared
    1998-08-10

    (299 days)

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

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children.
    Device Description
    Microtiter ELISA kit detecting EBNA antibodies
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    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?
    Product Code :

    LLM

    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.
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    K Number
    K951549
    Device Name
    EBNA IGG EIA TEST SYSTEM
    Manufacturer
    IMMUNO PROBE, INC.
    Date Cleared
    1996-04-29

    (391 days)

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

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
    Device Description
    The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 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.
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    K Number
    K951822
    Device Name
    EBNA ENZYME IMMUNOASSAY KIT
    Manufacturer
    GRANBIO, INC.
    Date Cleared
    1996-02-15

    (301 days)

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

    LLM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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