Device Dossier
Clinical chemistry hormone IVDs
Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Abacus dx). ARTG record, intended purpose,…
- GMDN category: CT850 - Clinical chemistry hormone IVDs
Intended purpose
The RAMP Total b-hCG test is a quantitative immunochromatographic assay indicated for use as an in vitro diagnostic product used with a RAMP 200 instrument to measure levels of beta-human chorionic gonadotropin (b-hCG) in human EDTA anti-coagulated whole blood. RAMP Total b-hCG is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the determination of early pregnancy. The RAMP Total β-hCG Controls are intended for in vitro diagnostic use in the quality control of the RAMP Total β-hCG assay on the RAMP Platform.