BEUDAMED
    Product Code: LOK FDA class 3

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    Unknown

    Kit, Test, Alpha-Fetoprotein for Neural Tube Defects is a maternal serum or amniotic fluid diagnostic test that measures alpha-fetoprotein (AFP) levels to screen for open neural tube defects such as spina bifida and anencephaly, as well as other fetal abnormalities, during the second trimester of pregnancy. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LOK; no regulation number has been assigned, and the review panel is Immunology. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LOK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    IM
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.