BEUDAMED
    Product Code: MZF FDA class 2 21 CFR 866.3956

    Test, Hiv Detection

    Microbiology

    The HIV Detection Test is an in vitro diagnostic device used to detect human immunodeficiency virus (HIV) infection through serological or molecular methods. These tests play a critical role in blood donor screening and clinical diagnosis of HIV infection. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.3956 (Microbiology specialty).

    View on FDA
    510(k)s
    0
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MZF
    Device Class
    FDA class 2
    Regulation Number
    866.3956
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.