BEUDAMED
    Product Code: PNK FDA class 3

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    Unknown

    The Fluorescence In Situ Hybridization, Chromosome 17p Deletion (TP53) (product code PNK) is a Class 3 in vitro diagnostic device using a FISH kit to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL). Class 3 devices require Premarket Approval (PMA). The assay has no assigned regulation number or formal medical specialty designation and is not an implant or life-sustaining device.

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

    Basic Information

    Product Code
    PNK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    MG
    Submission Type
    2

    Device Characteristics

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

    Definition

    A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).

    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.