BEUDAMED
    Product Code: QQB FDA class 2 21 CFR 862.1622

    Prognostic Test For Assessment Of Liver Related Disease Progression

    Clinical Chemistry

    The Prognostic Test for Assessment of Liver Related Disease Progression is a clinical chemistry device that measures one or more analytes from human samples to aid in assessing the progression of liver-related disease, and is not intended for disease diagnosis, therapeutic monitoring, assessment of progression to hepatocellular carcinoma, or detection of viruses or viral antigens. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 862.1622 in the Clinical Chemistry specialty. It carries product code QQB and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QQB
    Device Class
    FDA class 2
    Regulation Number
    862.1622
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    prognostic test for assessment of liver related disease progression is intended to measure one or more analytes obtained from human samples as an aid in assessing progression of liver related disease. This device is not intended for diagnosis of any disease, for monitoring the effect of any therapeutic product, for assessing progression to hepatocellular carcinoma, or for assessing disease progression in individuals with viral hepatitis. It is also not intended for the detection of viruses, viral antigens, or antibodies to viruses.

    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
    DEN190056 ADVIA Centaur Enhanced Liver Fibrosis (ELF)

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.