Device Dossier
Haemoglobin IVDs
Device Dossier for Haemoglobin IVDs (CT880 - Haemoglobin IVDs, Class 2, sponsor Abacus dx). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT880 - Haemoglobin IVDs
Intended purpose
FMH QuikQuant (QQF100) is a flow cytometric kit manufactured formerly by Trillium Diagnostics and now by IQ Products for Foeto Maternal Haemorrhage (FMH) detection and quantitation. The assay uses an Anti-Haemoglobin F antibody and Propidium Iodide reagent in a rapid, streamlined technique requiring approximately 30 minutes to complete. It measures the amount of HbF in maternal blood.