BEUDAMED
    Product Code: QIP FDA not classified

    Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

    Unknown

    Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents are in vitro diagnostic tests or reagents used to detect IgG and/or IgM antibodies to Rickettsia species in human serum or plasma, intended to aid in the diagnosis of present or past infection with Rickettsia in patients suspected of exposure to spotted fever or typhus group organisms. The device is classified as Not Classified (Class N), reviewed by the Microbiology panel, with no regulation number assigned. The product code is QIP. The device is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QIP
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure.

    Unclassified Reason

    3