BEUDAMED
    Product Code: QZG FDA class 2 21 CFR 862.1675

    Menstrual Blood Collection Device

    Clinical Chemistry

    The menstrual blood collection device (product code QZG) is a Class 2 Clinical Chemistry device (regulation 862.1675) intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing. It requires 510(k) clearance. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QZG
    Device Class
    FDA class 2
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing

    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.