BEUDAMED
    Product Code: LKV FDA class 3

    Enzyme Immunoassay, Fetal Fibronectin

    Unknown

    Enzyme Immunoassay, Fetal Fibronectin is a diagnostic test that measures fetal fibronectin levels in cervicovaginal secretions, used as a predictor of preterm labor risk; its result assists clinicians in identifying pregnant women at risk for premature delivery within a short time window. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LKV; no regulation number has been assigned. The review panel is Clinical Chemistry.

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    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    LKV
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.