BEUDAMED
    16 results · 48ms · 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 MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code LCO·July 19, 2019

    BIOPHEN UFH Control C1, REF 224101

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

    BIOPHEN UFH Control Plasma

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·June 28, 2022

    BIOPHEN UFH Control C2, REF 223901

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

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

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

    BIOPHEN LMWH Control C4, REF 224201

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code GGN·March 19, 2019

    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

    FDA Recall
    Terminated ·Aniara Diagnostica LLC·Product code LCO·July 19, 2019

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

    FDA Enforcement
    Class II ·Ongoing·Aniara Diagnostica LLC·May 20, 2026

    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 Enforcement
    Class II ·Ongoing·Aniara Diagnostica LLC·March 15, 2023

    BIOPHEN UFH Control Plasma

    FDA Enforcement
    Class III ·Terminated·Aniara Diagnostica LLC·September 21, 2022

    BIOPHEN LMWH Control C4, REF 224201

    FDA Enforcement
    Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

    BIOPHEN UFH Control C1, REF 224101

    FDA Enforcement
    Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

    BIOPHEN UFH Control C2, REF 223901

    FDA Enforcement
    Class III ·Terminated·Aniara Diagnostica LLC·April 24, 2019

    ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Aniara Diagnostica LLC·August 28, 2019

    ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Aniara Diagnostica LLC·August 28, 2019