BEUDAMED
    3 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.

    FDA Enforcement
    Class II ·Terminated·TEM Systems Inc·November 2, 2016

    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

    FDA Enforcement
    Class II ·Terminated·TEM Systems Inc·April 15, 2015

    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.

    FDA Enforcement
    Class II ·Terminated·TEM Systems Inc·March 16, 2016