BEUDAMED
    Product Code: GQP FDA class 1 21 CFR 866.3400

    Antisera, Neutralization, Parainfluenza Virus 1-4

    Microbiology

    The Antisera, Neutralization, Parainfluenza Virus 1-4 is a laboratory reagent antiserum used in neutralization assays to identify and serotype parainfluenza viruses (types 1 through 4) in clinical specimens. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket submission. The product code is GQP, regulated under 21 CFR 866.3400 in the Microbiology specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    4

    Research product code GQP in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    GQP
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K981226 IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
    K933575 VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT