BEUDAMED
    Product Code: GPN FDA class 1 21 CFR 866.3500

    Antiserum, Typhus Fever

    Microbiology

    The Typhus Fever Antiserum is a serological reagent used in complement fixation or related tests to detect antibodies against Rickettsia prowazekii, the causative agent of epidemic typhus, a louse-borne disease historically associated with wartime conditions and overcrowding. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GPN, regulated under 21 CFR 866.3500 in the Microbiology specialty.

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    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GPN
    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
    K864110 RICKETTSIAL IGG AND IGM IFA KIT

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.