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

    VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

    K Number: K132843 · Decision Jan 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    120

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    Basic Information

    Device Name
    VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
    K Number
    K132843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosphere, Inc.
    Date Received
    September 10, 2013
    Decision Date
    January 8, 2014
    Product Code
    PEN
    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
    PEN Gram-Negative Bacteria And Associated Resistance Markers

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    Other Clearances by Nanosphere, Inc.

    K Number Device Name
    K143653 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
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    K123197 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
    K120466 VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
    K122514 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
    DEN120014 VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
    K112424 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
    K103209 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
    K093337 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
    K092957 VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
    Search all 16 clearances from Nanosphere, Inc. →