Device Dossier

Coagulation factor IVDs

Device Dossier for Coagulation factor IVDs (CT877 - Coagulation factor IVDs, Class 2, sponsor Diagnostica Stago). ARTG record, intended purpose, GMDN…

Intended purpose

IVD,s that are intended to be used for the qualitative and/or Quantitative determination if individual clotting factors within the coagulation cascade. Coagulation factor II (prothombin) , Coagulation factor IIa (thrombin), Coagulation factor IX, Coagulation factor prekallikrein/kallikrein, Coagulation factor V, Coagulation factor VII, Coagulation factor VIIa, Coagulation factor VIII, Coagulation factor VIII ristocetin co factor activity, Coagulation factor VIII -associated antigen ,Coagulation factor X, Coagulation factor XI, Coagulation factor FXII, Coagulation factor FXIII, vwf- CBA,

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