BEUDAMED
    Product Code: ORL FDA class 3

    Whole Blood Pre-Treatment T-Cell Enrichment Reagent

    Unknown

    The Whole Blood Pre-Treatment T-Cell Enrichment Reagent (product code ORL) is a reagent used for the pre-treatment of whole blood prior to lymphocyte separation, aiding in the removal of selected white blood cells from whole blood stored at room temperature. It is used as a preparatory step in immunological assays and cell separation procedures. This device is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA) to demonstrate safety and effectiveness, with no specific regulation number assigned. The medical specialty is not formally designated, and the device is reviewed by the Microbiology panel. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    ORL
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    2

    Device Characteristics

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

    Definition

    The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C).