BEUDAMED
    Product Code: PRA FDA class 2 21 CFR 866.3316

    Variola Virus Nucleic Acid-Based Detection Assay

    Microbiology

    The Variola Virus Nucleic Acid-Based Detection Assay is a qualitative diagnostic test for the detection of Variola virus (the causative agent of smallpox) nucleic acid from clinical specimens, intended for individuals presenting with pustular or vesicular rash illness or other symptoms consistent with Variola infection. It is classified as FDA Class 2 under 21 CFR 866.3316 in the Microbiology specialty, requiring 510(k) clearance, and results must be used in conjunction with other diagnostic assays and clinical observations as defined by appropriate public health authorities. Product code PRA; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PRA
    Device Class
    FDA class 2
    Regulation Number
    866.3316
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN160016 Variola virus Real-Time PCR Assay

    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.