BEUDAMED
    Product Code: GNR FDA class 1 21 CFR 866.3330

    Antisera, Neutralization, Influenza Virus A, B, C

    Microbiology

    The Neutralization Antisera for Influenza Virus A, B, and C are reference reagents used in virus neutralization assays to identify and subtype influenza virus isolates from clinical specimens, supporting surveillance and diagnosis of influenza infections. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNR, regulated under 21 CFR 866.3330 in the Microbiology specialty.

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

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    Basic Information

    Product Code
    GNR
    Device Class
    FDA class 1
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    4

    Device Characteristics

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

    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
    K984596 VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES