BEUDAMED
    Product Code: PRF FDA not classified

    Docetaxel / Paclitaxel Assay

    Unknown

    The Docetaxel/Paclitaxel Assay is a diagnostic test intended to measure levels of the chemotherapy drugs Docetaxel or Paclitaxel in the blood, used in therapeutic drug monitoring for cancer patients receiving taxane-based chemotherapy. It is currently unclassified (not classified by FDA panel action) and reviewed by the Clinical Toxicology panel; it does not have an assigned regulation number. The device received a "not classified" determination (unclassified reason code 3), meaning its classification has not been established through the standard process. Product code PRF; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PRF
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    TX
    Submission Type
    3

    Device Characteristics

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

    Definition

    Measures levels of Docetaxel or Paclitaxel in the blood

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.