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

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P790019 · Supplement: S016 · Decision Nov 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    HAVAB-M EIA
    PMA Number
    P790019
    Supplement Number
    S016
    Device Class
    FDA Class 2
    Product Code
    LOL
    Generic Name
    Hepatitis a test (antibody and igm antibody)
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 6, 2002
    Date Received
    October 7, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO 1) REPLACE LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM LITTON BIONETICS WITH NON-LYOPHILIZED GOAT ANTI-HUMAN IGM PURCHASED FROM JACKSON IMMUNO RESEARCH. 2) REPLACE RHEOPHORESIS TESTING FOR GOAT ANTI-HUMAN IGM (ANTIBODY) IDENTITY/SPECIFICITY WITH IMMUNOELECTRO-PHORESIS (IEP) TESTING. 3) REPLACE HAVAB-M RIA (RADIOIMMUNOASSAY) ANTIBODY BEAD COAT EFFICACY TESTING WITH SMALL-SCALE ANTIBODY DILUTION FACTOR DETERMINATION AND CONFIRMATION TESTING USING HAVAB-M EIA (ENZYME IMMUNOASSAY) TO ESTABLISH THE OPTIMAL DILUTION FACTOR OF THE GOAT ANTI-HUMAN IGM ANTIBODY TO BE USED FOR FULL-SCALE PRODUCTION BEAD COATING.

    Classifications

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

    Product Code Device Name
    LOL Hepatitis A Test (Antibody And Igm Antibody)