BEUDAMED
    Product Code: IAL FDA class 1 21 CFR 864.4010

    Iodine (Tincture)

    Pathology

    Iodine Tincture is a chemical solution used in histology and pathology as a reagent to detect the presence of glycogen and starch (producing a blue-black color) in tissue sections, and also serves as a mordant in some staining procedures. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IAL, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
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    Basic Information

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

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.