BEUDAMED
    Product Code: HZX FDA class 1 21 CFR 864.1850

    Silver Nitrate

    Hematology

    Silver Nitrate is a chemical reagent used in histology for silver impregnation methods to demonstrate reticular fibers, nerve fibers, and certain microorganisms in tissue sections. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is HZX, regulated under 21 CFR 864.1850, in the Hematology medical specialty. This device is exempt from GMP requirements.

    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
    HZX
    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.