BEUDAMED
    Product Code: PIT FDA class 1 21 CFR 866.3870

    Leishmania Spp. Antigen Detection Assay

    Microbiology

    The Leishmania Spp. Antigen Detection Assay is an in vitro diagnostic test intended to detect Leishmania species antigens in patient specimens as an aid in the diagnosis of Leishmania infection. It is an FDA Class 1 device regulated under 21 CFR 866.3870, subject to general controls, within the Microbiology (MI) specialty. The product code is PIT, and it is eligible for third-party review. This device is not an implant and is not life-sustaining.

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    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PIT
    Device Class
    FDA class 1
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.

    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
    K141341 CL DETECT RAPID TEST

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.