BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    PMA: P970055 · Decision Aug 6, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
    Trade Name
    BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
    PMA Number
    P970055
    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
    August 6, 1999
    Date Received
    August 28, 1997
    Expedited Review
    N
    Docket Number
    00M-1215

    Advisory Committee Statement

    The device is intended for the qualitative detection if IgM antibodies to B19 virus (B19V, previously known as human parvovirus B19) in human seru, lithium heparin, EDTA, and citrated plasma. This test, in conjunction with the Biotrin Parvovirus B19 IgG Enzyme Immunoassay, may be used for testing women of childbearing age to determine their serological status where there is a suspicion of exposure with B19V. The results of these assays may be used to make a serological determination of past, recent, or current infection with B19V. The clinician should consider the results of these assays as presumptive for risk of fetal infection with B19V. The test may also be used for all patients as an aid in the diagnosis of fifth disease (erythema infectiosum).

    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