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

    VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)

    K Number: K112424 · Decision Dec 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    23
    Applicant Total
    16
    Review Days
    115

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    Basic Information

    Device Name
    VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
    K Number
    K112424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosphere, Inc.
    Date Received
    August 23, 2011
    Decision Date
    December 16, 2011
    Product Code
    NQX
    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
    NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

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    Other Clearances by Nanosphere, Inc.

    K Number Device Name
    K143653 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
    K140083 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
    K132843 VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
    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)
    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. →