BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

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

    PMA: P000010 · Supplement: S016 · Decision Apr 7, 2010
    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
    AMPLICOR HCV TEST
    PMA Number
    P000010
    Supplement Number
    S016
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 7, 2010
    Date Received
    March 9, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE CIP PROCESS FOR THE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES, AND MINOR MODIFICATIONS TO THE HOPPER EQUIPMENT USED IN THE FORMULATION OF BULK REAGENTS FOR THE DEVICE.

    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