BEUDAMED
    Product Code: MAM FDA class 2 21 CFR 864.5220

    Dna-Probe, B And T Lymphocyte

    Hematology

    The B and T lymphocyte DNA probe is a hematology in vitro diagnostic device used to detect and differentiate B-cell and T-cell lymphocyte populations through nucleic acid hybridization techniques, supporting diagnosis of lymphoid disorders. It is classified as FDA Class II under 21 CFR 864.5220 within the Hematology specialty, requiring 510(k) premarket clearance. The product code is MAM and the device is not implanted. Full GMP compliance is required and it is not eligible for third-party review.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MAM
    Device Class
    FDA class 2
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K923951 CD8 CYTOSPHERES KIT