Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Endotherapeutics). ARTG record, intended…

Intended purpose

The ADEXUSDx hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood (capillary or venous), plasma, or serum and is indicated as an aid for healthcare professionals in the diagnosis of early pregnancy.

TGA Public Summary