BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P980018 · Supplement: S026 · Decision Jan 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    HercepTest™
    PMA Number
    P980018
    Supplement Number
    S026
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 28, 2026
    Date Received
    December 29, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for specific labeling change to provide clearer instructions for use, which will improve user compliance and reduce errors, thereby ensuring consistent staining results.

    Classifications

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

    Product Code Device Name
    MVC System, Test, Her-2/Neu, Ihc