BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P030056 · Supplement: S008 · Decision Mar 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ADVIA CENTAUR HCV READYPACKS
    PMA Number
    P030056
    Supplement Number
    S008
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 2015
    Date Received
    September 15, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CLAIM TO TEST A PEDIATRIC POPULATION WITH THE FDA APPROVED ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS AND IS INDICATED FOR:ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ADVIA CENTAUR HCV (AHCV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN PEDIATRIC (18 MONTHS ¿ 21 YEARS) AND ADULT SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION.ADVIA CENTAUR CP SYSTEM: THE ADVIA CENTAUR HCV (AHCV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN PEDIATRIC (18 MONTHS ¿ 21 YEARS) AND ADULT SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION TO AID IN THE DIAGNOSIS OF INDIVIDUALS WITH SYMPTOMS OF HEPATITIS AND IN INDIVIDUALS AT RISK FOR HEPATITIS C INFECTION.

    Classifications

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

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus