BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    PMA: P150015 · Supplement: S039 · Decision Nov 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Trade Name
    cobas HCV
    PMA Number
    P150015
    Supplement Number
    S039
    Device Class
    FDA Class 2
    Product Code
    MZP
    Generic Name
    Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 2, 2020
    Date Received
    July 24, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    changes to the cobas HBV Assay Specific Analytical Package (ASAP) software for use with the cobas HBV test (P150014) and cobas HCV ASAP software for use with the cobas HCV test (P150015) for use with the cobas 6800/8800

    Classifications

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

    Product Code Device Name
    MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus