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
IQ Products manufactures a kit called the Fetal Cell Count Kit which is used to measure HbF levels. It is a class 2 IVD GMND Code CT880 - IVD that are intended to for quantitative determination of Haemoglobin and the various subtypes of Haemoglobin in a clinical specimen