BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

    K Number: K033106 · Decision Jul 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    11
    Review Days
    287

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    Basic Information

    Device Name
    CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
    K Number
    K033106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech USA
    Date Received
    September 30, 2003
    Decision Date
    July 13, 2004
    Product Code
    MYF
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

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