BEUDAMED
    Product Code: GQR FDA class 1 21 CFR 866.3400

    Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

    Microbiology

    The Antigens, HA (Including HA Control), Parainfluenza Virus 1-4 consists of hemagglutination antigens and controls for use in laboratory testing to identify parainfluenza viruses types 1 through 4. As an FDA Class 1 device, it is considered low risk and subject only to general controls, with no premarket clearance required. The product code is GQR, 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
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GQR
    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
    K812365 PARA 1 SENDAI HEMAGGLUTININ

    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.