BEUDAMED
    Product Code: IDA FDA class 1 21 CFR 864.1850

    Alcian Blue

    Hematology

    Alcian Blue is a polyvalent basic dye used in histology to stain acidic polysaccharides and mucins in tissue sections, producing a blue coloration in structures containing hyaluronic acid, heparan sulfate, and other acidic glycosaminoglycans. 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 IDA, 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
    2
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    IDA
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K832496 BIO SURE STAIN
    K801143 VOLU-SOL URINARY DICHROME STAIN

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.