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CLIA & FDA Replacement Reagent & Instrument Policy

  • 1.  CLIA & FDA Replacement Reagent & Instrument Policy

    Posted 13-Mar-2015 15:35
    Should in the past, a moderate risk instrument / reagent family add a moderate risk instrument to the instrument family and not request a CLIA category.... Does the added instrument system automatically become high risk?
    This does not seem logical to me.
    Comments & advise are greatly appreciated.

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    Richard Davis PHD, RAC
    Consultant
    Richard H. Davis Inc.
    San Diego CA
    United States
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