BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    PMA: P040005 · Supplement: S002 · Decision Feb 13, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Nucleic Acid Or Serum
    Trade Name
    HER2 FISH PHARMDX KIT
    PMA Number
    P040005
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    MVD
    Generic Name
    SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 13, 2008
    Date Received
    October 29, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE CEN 17 REFERENCE PNA PROBES IN VIAL 3 PROBE MIX, ADJUSTMENT OF THE HER2 GENE TARGETED DNA PROBE CONCENTRATIONS IN VIAL 3 PROBE MIX, CHANGE IN AUXILIARY MATERIALS IN TEXAS RED NICK TRANSLATION AND USE OF SEPHADEX G-50 COLUMNS FOR PURIFICATION OF NICK TRANSLATION PRODUCTS.

    Classifications

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

    Product Code Device Name
    MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum