BEUDAMED
    Product Code: HYZ FDA class 1 21 CFR 864.1850

    Methenamine Silver

    Hematology

    Methenamine Silver is a histological stain used to detect fungi, basement membranes, and reticular fibers in tissue sections, working by reducing silver ions to metallic silver at sites of aldehyde groups. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls only with no premarket submission required. The product code is HYZ, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HYZ
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    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.