BEUDAMED
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    Filters Classification: Class Ii ×

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Enforcement
    Class II ·Ongoing·Medical Information Technology, Inc.·September 24, 2025

    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 19, 2012