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510(k) Data Aggregation

    K Number
    K021610
    Device Name
    QAB2A IGM ELISA KIT HRP
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-07-12

    (57 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QAß2A IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgM antibodies to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.
    Device Description
    Not Found
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    K Number
    K021611
    Device Name
    QAB2A IGG ELISA KIT HRP
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-07-12

    (57 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.
    Device Description
    Not Found
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    K Number
    K021192
    Device Name
    QACA IGG/IGM ELISA KIT HRP
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-05-16

    (31 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum. The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.
    Device Description
    Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.
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    K Number
    K020694
    Device Name
    QAB2A IGM ELISA KIT
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-04-19

    (46 days)

    Product Code
    MVS
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QAB2A IgM Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgM isotype autoantibody to ß2-Glycoprotein-1 in human serum. The presence of ß2-GP1 antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.
    Device Description
    Not Found
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    K Number
    K020695
    Device Name
    QAB2A IGG ELISA KIT
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-04-19

    (46 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.
    Device Description
    Not Found
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    K Number
    K020241
    Device Name
    QACA IGG/IGM ELISA KIT
    Manufacturer
    CHESHIRE DIAGNOSTICS LTD.
    Date Cleared
    2002-03-13

    (49 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESHIRE DIAGNOSTICS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit is an enzyme linked immunoassay for the in vitro semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum.
    Device Description
    Not Found
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