BEUDAMED
    Product Code: NHS FDA class 2 21 CFR 866.3950

    Assay, Genotype, Hiv Drug Resistance, In Vitro

    Immunology

    The Assay, Genotype, HIV Drug Resistance, In Vitro (product code NHS) is an in vitro diagnostic assay that performs HIV-1 drug resistance genotyping by sequencing the viral genome to identify mutations associated with resistance to antiretroviral drugs, as described in its definition. It is classified as an FDA Class 2 device within the Immunology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NHS
    Device Class
    FDA class 2
    Regulation Number
    866.3950
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    Hiv-1 drug resistance genotyping