BEUDAMED
    Product Code: GQE FDA class 1 21 CFR 866.3490

    Antisera, Neutralization, All Types, Rhinovirus

    Microbiology

    The Rhinovirus Neutralization Antisera (All Types) are reference reagents used in virus neutralization tests to identify and type rhinovirus isolates, the predominant causative agents of the common cold and a contributing factor in asthma exacerbations and other respiratory illnesses. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GQE, regulated under 21 CFR 866.3490 in the Microbiology specialty.

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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    GQE
    Device Class
    FDA class 1
    Regulation Number
    866.3490
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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