BEUDAMED
    Product Code: OYV FDA class 2 21 CFR 866.5970

    Inherited Nucleotide Repeat Disorder Dna Test

    Immunology

    The Inherited Nucleotide Repeat Disorder DNA Test is a prescription in vitro diagnostic test designed to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens, intended as an aid for carrier testing and diagnosis of inherited nucleotide repeat-associated disorders (such as Huntington's disease or fragile X syndrome), to be used in conjunction with other clinical and diagnostic findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYV, with regulation number 866.5970 under the Immunology specialty, reviewed by the pathology panel.

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

    Basic Information

    Product Code
    OYV
    Device Class
    FDA class 2
    Regulation Number
    866.5970
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

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

    Definition

    An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN190023 AmplideX Fragile X Dx & Carrier Screen Kit

    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.