BEUDAMED
    Product Code: KEF FDA class 1 21 CFR 864.4010

    Paraformaldehyde

    Pathology

    Paraformaldehyde is a dry polymerized form of formaldehyde used as a tissue fixative in histopathology and immunohistochemistry laboratories, dissolved to prepare fresh formaldehyde solutions for the fixation and preservation of biological specimens prior to sectioning and staining. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KEF is regulated under 21 CFR 864.4010 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KEF
    Device Class
    FDA class 1
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    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 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.