BEUDAMED
    Product Code: GPP FDA class 1 21 CFR 866.3500

    Antiserum, Rocky Mountain Spotted Fever

    Microbiology

    The Rocky Mountain Spotted Fever Antiserum is a reference reagent used in serological tests to detect antibodies against Rickettsia rickettsii, the causative agent of Rocky Mountain spotted fever (RMSF), a potentially fatal tick-borne rickettsial disease. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPP, regulated under 21 CFR 866.3500 in the Microbiology specialty.

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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
    GPP
    Device Class
    FDA class 1
    Regulation Number
    866.3500
    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
    K843794 LATEX-R RICKETTSII