BEUDAMED
    Product Code: MDC FDA class 2 21 CFR 866.3060

    Dna-Probe - Blastomyces Dermatitidis

    Microbiology

    The Blastomyces dermatitidis DNA probe is a microbiology in vitro diagnostic device that uses nucleic acid hybridization to detect Blastomyces dermatitidis in clinical specimens, enabling rapid identification of this fungus responsible for blastomycosis. It is classified as FDA Class II under 21 CFR 866.3060 within the Microbiology specialty, requiring 510(k) premarket clearance. The product code is MDC and the device is not implanted. Full GMP compliance is required.

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    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    MDC
    Device Class
    FDA class 2
    Regulation Number
    866.3060
    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
    K903201 ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST