BEUDAMED
    Product Code: OBF FDA class 2 21 CFR 866.3170

    Assay, Genotyping, Hepatitis C Virus

    Microbiology

    The Hepatitis C Virus Genotyping Assay (product code OBF) is an in vitro diagnostic device used for the qualitative detection and classification of eight clinically relevant Hepatitis C Virus (HCV) RNA genotypes in patient specimens. Knowing the HCV genotype is clinically important because it guides treatment selection and duration for antiviral therapy. This device is regulated under FDA Class 2, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device, and is subject to general and special controls. It falls under regulation 866.3170 in the Microbiology specialty and carries no implant or life-sustaining flags.

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

    Basic Information

    Product Code
    OBF
    Device Class
    FDA class 2
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes

    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.