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

    AIA-PACK TPOAb CONTROL SET

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·June 7, 2017

    Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience Inc·August 22, 2018

    AIA-PACK TgAb CONTROL SET

    FDA Enforcement
    Class III ·Terminated·Tosoh Bioscience, Inc.·June 7, 2017

    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706

    FDA Enforcement
    Class III ·Terminated·Tosoh Smd Inc·January 1, 2020