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510(k) Data Aggregation

    K Number
    K062183
    Device Name
    FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2006-11-21

    (113 days)

    Product Code
    LRM
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is intended for the in-vitro measurement of specific, high avidity IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other serological test results and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification letter for the FARRZYME Human High Avidity Anti-dsDNA Enzyme Immunoassay Kit. The document does not contain the detailed acceptance criteria and study information you requested. It primarily focuses on the FDA's substantial equivalence determination.

    Therefore, I cannot provide the requested information based on the provided text.

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