BEUDAMED
    Product Code: JZP FDA class 1 21 CFR 866.4600

    Plates, Ouchterlony Agar

    Immunology

    Plates, Ouchterlony Agar are immunological laboratory devices consisting of agar gel plates used to perform double immunodiffusion (Ouchterlony technique), in which antigens and antibodies diffuse toward each other to form visible precipitin lines, used for the detection and characterization of specific antibody-antigen systems. It is classified as FDA Class 1, posing the lowest risk and subject to general controls only. The product code is JZP, regulated under 21 CFR 866.4600, and falls within the Immunology medical specialty.

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

    Basic Information

    Product Code
    JZP
    Device Class
    FDA class 1
    Regulation Number
    866.4600
    Medical Specialty
    Immunology
    Review Panel
    IM
    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
    K761270 IMMUNO-TEC II OT AGAROSE PLATE KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.