BEUDAMED
    2 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code MMI·March 12, 2012

    Elecsys Troponin I STAT Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code MMI·March 12, 2012