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

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    Filters Classification: Class Iii ×

    S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.

    FDA Enforcement
    Class III ·Terminated·Medline Industries Inc·March 3, 2021

    Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

    FDA Enforcement
    Class III ·Terminated·Primus Corporation dba Trinity Biotech·December 7, 2022