Device Dossier

Clinical chemistry-specific protein IVDs

Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Helena Laboratories).…

Intended purpose

IVD's for the qualitative and quantitative measurement of Specific Proteins in human clinical samples: IDK Zonulin ELISA for the in vitro determination of Zonulin family peptides (ZFP) in stool; Lactoferrin ELISA for the in vitro determination of Lactoferrin in stool; IDK Calprotectin ELISA for the in vitro determination of Calprotectin (MRP 8/14, S100A8/A9) in stool; IDK sIgA ELISA For the in vitro determination of secretory IgA in saliva and stool

TGA Public Summary