Device Dossier
Clinical chemistry-specific protein IVDs
Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Emergo). ARTG record,…
- GMDN category: CT974 - Clinical chemistry-specific protein IVDs
Intended purpose
The DNlite uPTM-FetA ELISA Kit is a colorimetric immunoassay to quantify unique Fetuin-A with specific post translational modification (hereafter called as E103) in urine. This product is a non-automated IVD for prognosis use and should be performed at qualified clinical laboratories by certified medical professionals, such as Medical Technologists. The concentration of E103 should be corrected by urine creatinine before applying to the clinic. The DNlite uPTM-FetA ELISA Kit is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of kidney function in type 2 diabetes and kidney transplantation recipients.