BEUDAMED
    Product Code: IBB FDA class 1 21 CFR 864.4010

    Phytohemaglutinin M

    Pathology

    Phytohemagglutinin M (PHA-M) is a lectin derived from kidney beans used in cytogenetics laboratories to stimulate lymphocyte proliferation and mitosis in cell culture, enabling chromosome analysis and karyotyping. 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 IBB, 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
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    IBB
    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 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.