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    K Number
    K030849
    Device Name
    AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
    Manufacturer
    N-DIA, INC.
    Date Cleared
    2004-02-02

    (322 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    N-DIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AmniSure™ ROM (Rupture Of [fetal] Membranes) Test is a rapid, noninstrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.
    Device Description
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