8 results
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51ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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