BEUDAMED
    Product Code: MTG FDA class 3

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    Unknown

    A Free (Noncomplexed) Prostate Specific Antigen Test is an in vitro diagnostic device that measures the proportion of unbound PSA relative to total PSA in serum, used to help distinguish between prostate cancer and benign prostatic conditions such as benign prostatic hyperplasia, thereby improving specificity of PSA-based screening. It is FDA Class 3, requiring PMA approval, with product code MTG. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MTG
    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 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.