Device Dossier

Coagulation calibrator/control IVDs

Device Dossier for Coagulation calibrator/control IVDs (CT872 - Coagulation calibrator/control IVDs, Class 2, sponsor Abacus dx). ARTG record, intended…

Intended purpose

This product is intended for use with Mindray automated coagulation analyzers for the calibration and quality control of coagulation testing, including monitoring precision and detecting analytical deviations, for example in assays such as AT, PT, APTT, FIB, TT, D‑Dimer, and FDP.

TGA Public Summary