BEUDAMED
    Product Code: MYR FDA class 2 21 CFR 866.3830

    Test, Donor, Syphilis, Antigens, Treponemal

    Microbiology

    The Donor Syphilis Treponemal Antigen Test is an in vitro diagnostic device used to screen blood donors for syphilis infection by detecting antibodies against treponemal antigens of Treponema pallidum. Treponemal tests are highly specific for syphilis and are used in blood banking to ensure the safety of the blood supply. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.3830 (Microbiology specialty).

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

    Basic Information

    Product Code
    MYR
    Device Class
    FDA class 2
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.