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510(k) Data Aggregation

    K Number
    K083430
    Device Name
    REAL-TIME PCR INTERNAL CONTROL 2B SET
    Manufacturer
    NANOGEN, INC.
    Date Cleared
    2009-01-15

    (57 days)

    Product Code
    OLD
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANOGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Real-Time PCR Internal Control 2B Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control 2B Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
    Device Description
    Not Found
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    K Number
    K051596
    Device Name
    STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
    Manufacturer
    NANOGEN, INC.
    Date Cleared
    2006-03-13

    (270 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    Why did this record match?
    Applicant Name (Manufacturer) :

    NANOGEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
    Device Description
    The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
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