BEUDAMED
    Product Code: JBB FDA class 2 21 CFR 864.7825

    Solubility, Hemoglobin, Abnormal

    Hematology

    Abnormal hemoglobin solubility reagents and test systems are used in clinical hematology laboratories to screen blood samples for the presence of hemoglobin S and other sickling hemoglobins by exploiting their reduced solubility under deoxygenated conditions, aiding in the diagnosis of sickle cell disease and related disorders. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JBB, regulated under 21 CFR 864.7825, within the Hematology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    4

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    Basic Information

    Product Code
    JBB
    Device Class
    FDA class 2
    Regulation Number
    864.7825
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K932872 SICKLE CELL TEST KIT
    K895745 SICKLE CELL SOLUBILITY TEST KIT