BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Accelerate PhenoTest BC kit REF 10101018

    FDA Enforcement
    Class II ·Ongoing·Accelerate Diagnostics Inc·December 7, 2022

    Accelerate PhenoTest BC kit REF 10102018

    FDA Enforcement
    Class II ·Ongoing·Accelerate Diagnostics Inc·December 7, 2022

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of immobilized growing bacterial cells when used with Accelerate PhenoTest kits.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·April 3, 2019