BEUDAMED
    Product Code: GRB FDA class 1 21 CFR 866.3380

    Antiserum, Cf, Mumps Virus

    Microbiology

    The Antiserum, CF, Mumps Virus is a complement fixation antiserum used in serological laboratory testing to detect and measure antibody responses to the mumps virus. FDA Class 1 classification indicates low risk; only general controls apply and no premarket submission is required. The product code is GRB, regulated under 21 CFR 866.3380 in the Microbiology specialty. No special flags apply to this device.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    0

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    Basic Information

    Product Code
    GRB
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K872733 FIAX TEST KIT FOR MUMPS-G ANTIBODIES
    K872699 MUMPS CF ANTIGEN AND CONTROL ANTIGEN