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

    JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136

    K Number: K100287 · Decision Jul 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
    K Number
    K100287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3332
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U.S. Army Medical Material Development Command
    Date Received
    January 29, 2010
    Decision Date
    July 6, 2010
    Product Code
    NXD
    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
    NXD Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

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