BEUDAMED
    Product Code: LJZ FDA class 1 21 CFR 866.3375

    Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

    Microbiology

    Enzyme Linked Immunosorbent Assay (ELISA), Mycoplasma Spp. is a serological diagnostic assay used to detect antibodies against Mycoplasma species, which are bacteria associated with respiratory tract infections, pneumonia, and other systemic conditions. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LJZ, regulated under 21 CFR 866.3375, within the Microbiology medical specialty. No special flags apply to this device.

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    510(k)s
    13
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    8
    Years Active
    16

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    Basic Information

    Product Code
    LJZ
    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 13 510(k) clearances via K numbers.

    K Number Device Name
    K984153 THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
    K971503 MYCOPLASMA IGM ELISA TEST SYSTEM
    K971393 MYCOPLASMA IGG ELISA TEST SYSTEM
    K970150 MYCOPLASMA IGG ELISA TEST SYSTEM
    K963054 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
    K963055 IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120
    K934550 IMMUNOCARD MYCOPLASMA
    K920212 MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
    K921556 MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
    K904501 MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
    K895276 DIATECH IGM-MP TEST
    K882596 MP TEST
    K823804 MYCOPLASMELISA TEST KIT

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.