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510(k) Data Aggregation

    K Number
    K010301
    Device Name
    IMMUNOWELL EA (D) IGG TEST
    Manufacturer
    GenBio
    Date Cleared
    2001-06-11

    (130 days)

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

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974226
    Device Name
    IMMUNODOT MONO-G TEST
    Manufacturer
    GenBio
    Date Cleared
    1998-09-22

    (314 days)

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

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome. This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
    Device Description
    The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.
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    K Number
    K974244
    Device Name
    IMMUNODOT MONO-M TEST
    Manufacturer
    GenBio
    Date Cleared
    1998-09-22

    (314 days)

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

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mono M Test is a qualitative enzyme immunoassay (EIA) that detects IgM antibodies to Paul-Bunnell heterophil, Epstein-Barr virus capsid antigen (EBV-VCA), and cytomegalovirus (CMV). When used in conjunction with Mono-G Test, it is as an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV mononucleosis-like syndrome. This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
    Device Description
    The product is an ELISA test method detecting heterophile, viral capsid antigen and cytomegalovirus IgM antibodies.
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    K Number
    K973939
    Device Name
    IMMUNOWELL VCA IGM TEST
    Manufacturer
    GenBio
    Date Cleared
    1998-08-10

    (299 days)

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

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).
    Device Description
    Microtiter ELISA kit detecting VCA IgM antibodies
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    K Number
    K973940
    Device Name
    IMMUNOWELL EBV VCA IGG TEST
    Manufacturer
    GenBio
    Date Cleared
    1998-08-10

    (299 days)

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

    GenBio

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

    GenBio

    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
    K963054
    Device Name
    IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
    Manufacturer
    GenBio
    Date Cleared
    1997-05-05

    (272 days)

    Product Code
    LJZ
    Regulation Number
    866.3375
    Why did this record match?
    Applicant Name (Manufacturer) :

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963055
    Device Name
    IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
    Manufacturer
    GenBio
    Date Cleared
    1997-05-02

    (269 days)

    Product Code
    LJZ
    Regulation Number
    866.3375
    Why did this record match?
    Applicant Name (Manufacturer) :

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K953682
    Device Name
    IMMUNO DOT BORRELIA DOT BLOT G TEST
    Manufacturer
    GenBio
    Date Cleared
    1996-05-03

    (270 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    GenBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K953683
    Device Name
    MMUNO DOT BORRELIA DOT BLOT M TEST
    Manufacturer
    GenBio
    Date Cleared
    1996-05-03

    (270 days)

    Product Code
    LSR
    Regulation Number
    866.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    GenBio

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

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