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510(k) Data Aggregation

    K Number
    K041068
    Device Name
    WEST NILE VIRUS IGG INDIRECT ELISA
    Manufacturer
    PANBIO LIMITED
    Date Cleared
    2004-10-20

    (177 days)

    Product Code
    NOP
    Regulation Number
    866.3940
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative presumptive detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease.
    Device Description
    The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis.
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    K Number
    K041231
    Device Name
    WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
    Manufacturer
    PANBIO LIMITED
    Date Cleared
    2004-08-10

    (92 days)

    Product Code
    NOP
    Regulation Number
    866.3940
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IoM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningioencephalitis or automated instruments. The user is responsible for establishing these assay performance characteristics. Caution: Cross-reactivity has been noted with the PANBIO West Nile IgM assay in specimens containing rheumatoid factor (RF). Reactive results must be reported with a caution statement regarding possible cross-reactivity with RF.
    Device Description
    The West Nile Virus IgM Capture ELISA is an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus in patients with clinical symptoms consistent with encephalitis / meningitis.
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    K Number
    DEN030004
    Device Name
    WEST NILE VIRUS IGM CAPTURE ELISA
    Manufacturer
    PANBIO LIMITED
    Date Cleared
    2003-07-08

    (5 days)

    Product Code
    NOP
    Regulation Number
    866.3940
    Why did this record match?
    Applicant Name (Manufacturer) :

    PANBIO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K030863
    Device Name
    EBV VCA-P18 IGG ELISA
    Manufacturer
    PANBIO LIMITED
    Date Cleared
    2003-06-27

    (101 days)

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

    PANBIO LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epstein-Barr Virus Viral Capsid-p18 Antigen (EBV VCA-p18) IgG ELISA 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-p18 IgG ELISA should be used in conjunction with other EBV serologies.
    Device Description
    The EBV VCA-p18 IgG ELISA is an Enzyme Linked Immunosorbent Assay for the qualitative detection of IgG antibodies in human serum to EBV VCA antigen.
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