BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Placental Alpha Microglobulin-1 Immunoassay

    PMA: P160052 · Supplement: S001 · Decision Oct 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Placental Alpha Microglobulin-1 Immunoassay
    Trade Name
    PartoSure Test
    PMA Number
    P160052
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    QBB
    Generic Name
    Placental alpha microglobulin-1 immunoassay
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 11, 2019
    Date Received
    May 11, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS) protocol

    Classifications

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

    Product Code Device Name
    QBB Placental Alpha Microglobulin-1 Immunoassay