BEUDAMED
    Product Code: QDI FDA class 2 21 CFR 864.1880

    Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

    Medical Genetics

    The FISH Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies is a Fluorescence In Situ Hybridization (FISH) test used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies, indicated for clinical management consistent with WHO guidelines and used in conjunction with other clinical and diagnostic criteria; results are interpreted by a pathologist or equivalent professional. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is QDI under regulation 864.1880 in the Medical Genetics specialty. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Research product code QDI in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QDI
    Device Class
    FDA class 2
    Regulation Number
    864.1880
    Medical Specialty
    Medical Genetics
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

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

    Definition

    Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional.

    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
    DEN170070 MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.