BEUDAMED
    2 results · 42ms · Sources: EU EUDAMED, US FDA

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    BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.

    FDA Recall
    Open, Classified ·Aniara Diagnostica LLC·Product code GGP·February 1, 2023

    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

    FDA Recall
    Open, Classified ·Aniara Diagnostica LLC·Product code LCO·April 1, 2026