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510(k) Data Aggregation

    K Number
    K142132
    Device Name
    POOL NORM
    Manufacturer
    Diagnostics Stago S.A.S.
    Date Cleared
    2014-12-12

    (130 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diagnostics Stago S.A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests: - APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers - dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers. This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.
    Device Description
    Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.
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