BEUDAMED
    Product Code: MBT FDA class 2 21 CFR 866.3320

    Dna-Probe, Reagent, Histoplasma Capsulatum

    Microbiology

    The Histoplasma capsulatum DNA probe reagent is a microbiology in vitro diagnostic device used to detect Histoplasma capsulatum nucleic acid in clinical specimens, supporting rapid diagnosis of histoplasmosis, a fungal infection. It is classified as FDA Class II under 21 CFR 866.3320 within the Microbiology specialty, requiring 510(k) premarket clearance. The product code is MBT 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
    MBT
    Device Class
    FDA class 2
    Regulation Number
    866.3320
    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
    K896859 ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST