BEUDAMED
    Product Code: MDJ FDA class 1 21 CFR 866.3200

    Reagents, Cysticercosis

    Microbiology

    The cysticercosis reagents are microbiology in vitro diagnostic devices used to detect antibodies or antigens related to Taenia solium larvae (cysticerci) in patient specimens, supporting diagnosis of neurocysticercosis and other forms of cysticercosis. They are classified as FDA Class I under 21 CFR 866.3200 within the Microbiology specialty, subject only to general controls. The product code is MDJ and the device is not GMP-exempt. It is not implanted and does not sustain life.

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    510(k)s
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MDJ
    Device Class
    FDA class 1
    Regulation Number
    866.3200
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K900780 CYSTICERCOSIS SEROLOGICAL REAGENTS

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.