BEUDAMED
    Product Code: SDP FDA class 2 21 CFR 864.1861

    Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit

    Hematology

    A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe detection kit is an in vitro diagnostic device intended as an aid in identifying hematolymphoid neoplasms, particularly for use when a hematolymphoid biopsy yields inconclusive results; it aids in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms by detecting kappa and lambda light chain mRNA expression patterns. It is classified as FDA Class II (510(k) required) under regulation 864.1861 in the Hematology specialty, reviewed by the Medical Genetics panel, with product code SDP. The device is not an implant and does not support life-sustaining functions.

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

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    Basic Information

    Product Code
    SDP
    Device Class
    FDA class 2
    Regulation Number
    864.1861
    Medical Specialty
    Hematology
    Review Panel
    MG
    Submission Type
    1

    Device Characteristics

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

    Definition

    A kappa and lambda immunoglobulin light chain in situ hybridization (ISH) mRNA probe is intended as an aid in the identification of hematolymphoid neoplasms using in situ hybridization. A Kappa and Lambda ISH mRNA probe cocktail is indicated for use when a hematolymphoid biopsy (e.g., bone marrow, lymphoid tissue) yields inconclusive results. The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms

    510(k) Clearance History

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    Related 510(k) Clearances

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

    K Number Device Name
    DEN240025 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

    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.