BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    PMA: P210040 · Supplement: S001 · Decision Jul 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
    Trade Name
    Agilent Resolution ctDx FIRST
    PMA Number
    P210040
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    PQP
    Generic Name
    Next generation sequencing oncology panel, somatic or germline variant detection system
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 27, 2023
    Date Received
    June 27, 2023
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the Instructions for Use for the Agilent Resolution Sample Collection Kit, a component of the Agilent Resolution ctDx FIRST assay

    Classifications

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

    Product Code Device Name
    PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System