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

    VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

    K Number: K123197 · Decision Dec 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    16
    Applicant Total
    16
    Review Days
    55

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    Basic Information

    Device Name
    VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
    K Number
    K123197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3130
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosphere, Inc.
    Date Received
    October 11, 2012
    Decision Date
    December 5, 2012
    Product Code
    OZN
    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
    OZN C. Difficile Toxin Gene Amplification Assay

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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)
    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. →