BEUDAMED
    3 results · 8ms · Sources: EU EUDAMED, US FDA

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    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

    FDA Enforcement
    Class III ·Terminated·Biocare Medical, LLC·June 3, 2015

    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

    FDA Enforcement
    Class III ·Terminated·Sentinel CH SpA·October 13, 2021

    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

    FDA Enforcement
    Class III ·Ongoing·Sentinel CH SpA·July 14, 2021