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510(k) Data Aggregation

    K Number
    K962762
    Device Name
    SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
    Manufacturer
    BIOTRACES, INC.
    Date Cleared
    1996-08-16

    (31 days)

    Product Code
    JJJ
    Regulation Number
    862.2320
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    Product Code :

    JJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SSMPD is intended as a general use clinical laboratory gamma radiation counter. The SSMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).
    Device Description
    The ssMPD is a twelve sample, bench-top gamma radiation counter that can be used to measure counts per minute and calculate disintegrations per minute emitted by multi-photon emission isotopes, including 125I. In volumes of 0.05 to 2.0 mls contained in 12 mm x 75 mm or 13 mm x 100 mm sample tubes disintegrations are measured over the range of 1 to 106 dpms. The sample tubes must be capped to minimize the possibility of contaminating the detector chamber. The full detector assembly is a twin detector system consisting of two scintillator crystals--each coupled to a high resolution planar photomultiplier. The entire detector is encased in a composite lead-tin-copper shield to minimize environmental background. In addition to permitting efficient counting of gamma emitters, the sample holder acts as a separator to reduce crosstalk within the twin scintillator detector assembly. The complete SSMPD system is comprised of a standalone SSMPD connected directly to a personal computer (PC) configured with SSMPD read-out electronics, MPDATA™ control and data logger software, and optionally, a printer.
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