BEUDAMED
    Product Code: MCE FDA class 1 21 CFR 866.3480

    Respiratory Syncytial Virus - Elisa

    Microbiology

    The respiratory syncytial virus (RSV) ELISA is a microbiology in vitro diagnostic device used to detect RSV antigens or antibodies in patient specimens, supporting diagnosis of RSV infections, particularly in infants, young children, and immunocompromised patients. It is classified as FDA Class I under 21 CFR 866.3480 within the Microbiology specialty, subject only to general controls. The product code is MCE and the device is not GMP-exempt. It is not implanted and does not sustain life.

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    510(k)s
    2
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    2
    Years Active
    14

    Basic Information

    Product Code
    MCE
    Device Class
    FDA class 1
    Regulation Number
    866.3480
    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
    K061008 QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
    K924289 KALLESTAD RSV MICROPLATE EIA

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.