BEUDAMED
    Product Code: QHO FDA unclassified 21 CFR 610.40

    Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

    Microbiology

    Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations are in vitro diagnostic devices intended for the qualitative detection of nucleic acid from infectious disease agents in human specimens, primarily for screening donated blood and plasma supplies. These devices are classified as Unclassified (Class U), governed by 21 CFR 610.40, and fall under the Microbiology medical specialty. The product code is QHO. These devices are not implants and are not flagged as life-sustaining.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QHO
    Device Class
    FDA unclassified
    Regulation Number
    610.40
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    3

    Device Characteristics

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

    Definition

    For the qualitative detection of nucleic acid for infectious disease agents in human specimens.

    Unclassified Reason

    1

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.