BEUDAMED
    2 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use

    FDA Enforcement
    Class II ·Terminated·Kamiya Biomedical Company, LLC·September 27, 2017

    K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

    FDA Enforcement
    Class II ·Ongoing·Kamiya Biomedical Company, LLC·November 30, 2022