BEUDAMED
    Product Code: NRF FDA class 2 21 CFR 864.8625

    Material, Quality Control, Semen Analysis

    Hematology

    The Semen Analysis Quality Control Material is a device used to determine the accuracy and precision of manual, semiautomated, and automated semen analysis instruments measuring parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cell count. It serves as a calibration and verification tool to ensure reliable performance of semen analysis systems in clinical laboratories. The device is FDA Class 2, regulated under 21 CFR 864.8625 in the Hematology specialty, with product code NRF, and is exempt from premarket notification under submission type 4. It is not an implant and does not provide life-sustaining support.

    View on FDA
    510(k)s
    3
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    3
    Years Active
    0

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    Basic Information

    Product Code
    NRF
    Device Class
    FDA class 2
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

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

    Definition

    A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K042750 QC-BEADS
    K041600 QWIKCHECK-BEADS
    K041240 SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

    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.