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    Maine Molecular Quality Controls, Inc.

    Manufacturer
    🇺🇸 United States·1 Importer

    MAINE MOLECULAR QUALITY CONTROLS, INC.

    FDA registration
    MAINE MOLECULAR QUALITY CONTROLS, INC.·4 products·🇺🇸 United States

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·December 13, 2023

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PEN·October 17, 2023

    Cruinn Diagnostics Ltd

    Importer
    🇮🇪 Ireland·6 Manufacturers

    QbD RepS BV

    Authorized representative
    🇧🇪 Belgium·86 Manufacturers·1555 Devices