BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    PMA: P150042 · Decision Sep 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
    Trade Name
    ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
    PMA Number
    P150042
    Device Class
    FDA Class 3
    Product Code
    MYM
    Generic Name
    ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 19, 2017
    Date Received
    November 19, 2015
    Expedited Review
    N
    Docket Number
    17M-5863

    Advisory Committee Statement

    Approval for the ZEUS ELISA Parvovirus B19 IgM Test System is intended for the qualitative detection of IgM class antibodies to human parvovirus B19 in human serum including women of childbearing age where there is a suspicion of exposure to human parvovirus B19. The test is also for all symptomatic patients as an aid in the diagnosis of fifth disease (erythema infectiosum). This test is for in vitro diagnostic use only.

    Classifications

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

    Product Code Device Name
    MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm