BEUDAMED
    Product Code: QST FDA class 2 21 CFR 866.3957

    Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

    Microbiology

    The Lab-Based HIV NAT Diagnostic and/or Supplemental Test is a prescription in vitro diagnostic device for the qualitative detection of HIV nucleic acid in human body fluids or tissues, used in clinical laboratory settings to diagnose HIV infection or to confirm results from screening assays. Nucleic acid testing (NAT) offers high sensitivity and specificity for HIV detection. Classified as FDA Class 2 under regulation 866.3957, it requires 510(k) clearance in the Microbiology specialty. The device is not an implant and not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QST
    Device Class
    FDA class 2
    Regulation Number
    866.3957
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.