BEUDAMED
    Product Code: GRZ FDA class 1 21 CFR 866.3375

    Antisera, Fluorescent, All, Mycoplasma Spp.

    Microbiology

    The Antisera, Fluorescent, All, Mycoplasma Spp. consists of fluorescent antisera used in immunofluorescence assays to detect and identify Mycoplasma species in clinical specimens, aiding in the diagnosis of atypical pneumonia and other mycoplasmal infections. It is an FDA Class 1 device, requiring only general controls with no premarket notification. Regulated under 21 CFR 866.3375 with product code GRZ in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    5
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    4
    Years Active
    12

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    Basic Information

    Product Code
    GRZ
    Device Class
    FDA class 1
    Regulation Number
    866.3375
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K946373 MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
    K944417 ZEUA MYCOPLASMA
    K931557 FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
    K861716 FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
    K840012 INDIRECT FLUORESCENT ANTIBODY MYCO