BEUDAMED
    Product Code: MZC FDA class 1 21 CFR 866.2560

    System, Detection, Bacterial, For Platelet Transfusion Products

    Microbiology

    The Bacterial Detection System for Platelet Transfusion Products is a microbiology device used to detect bacterial contamination in platelet concentrates prior to transfusion, a critical safety measure given that platelets are stored at room temperature and are susceptible to bacterial growth. Classified as FDA Class 1, it is subject to general controls under regulation 866.2560 (Microbiology specialty). This Class 1 device has been 510(k)-exempt (submission type 4).

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MZC
    Device Class
    FDA class 1
    Regulation Number
    866.2560
    Medical Specialty
    Microbiology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.