Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Laborie Medical Technologies). ARTG record,…

Intended purpose

ROM Plus is a visually interpreted qualitative IVD test intended for the detection of premature rupture of fetal membranes by detecting specific proteins in amniotic fluid. This test is for professional use only

TGA Public Summary