BEUDAMED
    Product Code: GRD FDA class 1 21 CFR 866.3380

    Antiserum, Hai, Mumps Virus

    Microbiology

    The Antiserum, HAI, Mumps Virus is a hemagglutination inhibition antiserum used in laboratory testing to identify and serotype the mumps virus. It is an FDA Class 1 device subject to general controls only, representing the lowest risk category with no premarket notification requirement. The product code is GRD, regulated under 21 CFR 866.3380 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
    GRD
    Device Class
    FDA class 1
    Regulation Number
    866.3380
    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
    K833077 WELLCOGEN H. INFLUENZAL ZL21

    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.