Device Dossier
Haemoglobin IVDs
Device Dossier for Haemoglobin IVDs (CT880 - Haemoglobin IVDs, Class 2, sponsor Revvity). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT880 - Haemoglobin IVDs
Intended purpose
The RESOLVE Systems Hemoglobin kit is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. The kit is designed to be run on a flat-bed electrofocusing unit. This assay is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies.