BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Enzyme Immunoassay, Fetal Fibronectin

    PMA: P920048 · Supplement: S029 · Decision Mar 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Enzyme Immunoassay, Fetal Fibronectin
    Trade Name
    Rapid fFN for the TLiIQ System
    PMA Number
    P920048
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    LKV
    Generic Name
    ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Toxicology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 5, 2026
    Date Received
    February 4, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    to change the sub-supplier for a chemical used in the manufacture of the Rapid fFN Control Kit and Rapid fFN Cassette Kit

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKV Enzyme Immunoassay, Fetal Fibronectin