BEUDAMED
    Product Code: PDX FDA class 2 21 CFR 864.5220

    Flow Cytometry Calibrator

    Hematology

    The Flow Cytometry Calibrator is a hematology device consisting of polystyrene or other particles with defined characteristics (such as number, size, scatter properties, and fluorescence intensity) used to standardize and calibrate flow cytometers to ensure consistent and accurate performance. It falls under the Hematology medical specialty and is classified as a Class 2 device under regulation 864.5220, requiring 510(k) premarket notification. Calibrators are essential quality control tools in clinical flow cytometry laboratories. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PDX
    Device Class
    FDA class 2
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.

    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.