Device Dossier

Thrombophilia and coagulation inhibitor IVDs

Device Dossier for Thrombophilia and coagulation inhibitor IVDs (CT876 - Thrombophilia and coagulation inhibitor IVDs, Class 2, sponsor Haemoview…

Intended purpose

Diagnostic test strip and controls intended to be used at point of care for qualitative detection of the absence or presence of direct oral anticoagulants (DOACs: Dabigatran, Apixaban, Edoxaban and Rivaroxaban) in human urine by visual identification of colours. For professional use only.

TGA Public Summary