BEUDAMED
    Product Code: MJK FDA class 1 21 CFR 866.2660

    Dna Probe, Trichomonas Vaginalis

    Microbiology

    The DNA Probe for Trichomonas vaginalis is a nucleic acid hybridization-based in vitro diagnostic test used to detect Trichomonas vaginalis DNA in vaginal swab specimens, enabling laboratory diagnosis of trichomoniasis, a common sexually transmitted infection. Classified as a Class 1 device under 21 CFR 866.2660 within the Microbiology specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    MJK
    Device Class
    FDA class 1
    Regulation Number
    866.2660
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K922457 AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.