Bio Preventive DNlite-DKD uPTM-FetA ELISA Kit - HSA Registration DE0509769
Access comprehensive regulatory information for Bio Preventive DNlite-DKD uPTM-FetA ELISA Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509769 and owned by Bio Preventive Medicine Corp.. The device was registered on September 11, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The DNlite-DKD uPTM-FetA ELISA Kit is a colorimetric immunoassay to quantify unique Fetuin-A with specific post translational modification (hereafter referred as E103) in urine. This product is an 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-DKD 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 patients with albuminuria.