BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P150014 · Decision Oct 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    COBAS HBV TEST
    PMA Number
    P150014
    Device Class
    FDA Class 3
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 14, 2015
    Date Received
    April 24, 2015
    Expedited Review
    N
    Docket Number
    15M-4069

    Advisory Committee Statement

    APPROVAL FOR THE COBAS HBV. THIS DEVICE IS INDICATED FOR: COBAS HBV IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN EDTA PLASMA OR SERUM OF HBV-INFECTED INDIVIDUALS. THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM COBAS HBV MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS.THE COBAS HBV IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKT Hepatitis Viral B Dna Detection