BEUDAMED
    Product Code: LSC FDA class 1 21 CFR 866.2660

    Neisseria Controls

    Microbiology

    Neisseria controls are quality control reagents used in microbiological testing laboratories to verify the performance and accuracy of identification systems for Neisseria species, including Neisseria gonorrhoeae and Neisseria meningitidis. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LSC, regulated under 21 CFR 866.2660, within the Microbiology medical specialty. No special flags apply to this device.

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    510(k)s
    7
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    0

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    Basic Information

    Product Code
    LSC
    Device Class
    FDA class 1
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Review Panel
    MI
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K840506 HAEMOPHILUS INFLUENZAE TYPE B
    K840514 NEISSERIA MENINGITIDIS CONTROL
    K840510 NEISSERIA MENINGITIDIS GR. A
    K840509 NEISSERIA MENINGITIDIS GR. B
    K840507 NEISSERIA MENINGITIDIS GR. Y
    K840505 SDL NEISSERIA MENNINGITIDIS GR. X
    K840504 SDL NEISSERIA MENINGITIDES GR. 2