BEUDAMED
    Product Code: GQQ FDA class 1 21 CFR 866.3400

    Antisera, Hai, Parainfluenza Virus 1-4

    Microbiology

    The Antisera, HAI, Parainfluenza Virus 1-4 is a hemagglutination inhibition (HAI) antiserum used to type and identify parainfluenza viruses 1 through 4 in laboratory serological assays. FDA Class 1 classification indicates minimal risk, with only general controls required and no premarket notification needed. The product code is GQQ, regulated under 21 CFR 866.3400 in the Microbiology specialty. No special flags apply to this device.

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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
    GQQ
    Device Class
    FDA class 1
    Regulation Number
    866.3400
    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
    K780007 GOAT ANTI-INFLUENZA ANTISERA