BEUDAMED
    Product Code: MDE FDA class 2 21 CFR 866.3165

    Dna-Probe, Reagents, Cryptococcal

    Microbiology

    The Cryptococcal DNA probe reagents are microbiology in vitro diagnostic devices that use nucleic acid hybridization to detect Cryptococcus species in clinical specimens, supporting rapid diagnosis of cryptococcal infections, which are particularly serious in immunocompromised patients. They are classified as FDA Class II under 21 CFR 866.3165 within the Microbiology specialty, requiring 510(k) premarket clearance. The product code is MDE 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
    MDE
    Device Class
    FDA class 2
    Regulation Number
    866.3165
    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
    K903556 ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST