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510(k) Data Aggregation

    K Number
    K250588

    Validate with FDA (Live)

    Device Name
    Access Rubella IgG
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2025-11-17

    (263 days)

    Product Code
    LFX
    Regulation Number
    866.3510
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K954687
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

    Device Description

    The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative detection of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.

    The Access Rubella IgG assay consists of the reagent pack, calibrators, and quality controls (QCs), packaged separately. Other items needed to run the assay include substrate and wash buffer.

    AI/ML Overview

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