Device Dossier
Coagulation calibrator/control IVDs
Device Dossier for Coagulation calibrator/control IVDs (CT872 - Coagulation calibrator/control IVDs, Class 2, sponsor Emergo). ARTG record, intended…
- GMDN category: CT872 - Coagulation calibrator/control IVDs
Intended purpose
Wondfo Coagulation Control (hereinafter, Coagulation Control or the control) is specially developed as the quality control material for Wondfo coagulation tests. Used along with Wondfo Optical Coagulation Analyzer, the Coagulation Control is intended to be a control of precision for the following Wondfo coagulation tests: Prothrombin Time Reagent Kit (Clotting), Activated Partial Thromboplastin Time Reagent Kit (Clotting), Fibrinogen Reagent Kit (Clotting), Activated Clotting Time Reagent Kit (Clotting), Thrombin Time Reagent Kit (Clotting) and Prothrombin Time PT/INR Reagent Kit (Clotting).