Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Beckman Coulter). ARTG…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
Intended purpose
The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative measurement of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For Professional Use Only. The Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. For professional use only.