DNlite-IVD103

Primary DI

D-4719879490015D9

Basic UDI-DI Code

B-4719879490015D9

Reference

DNlite-IVD103

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Bio Preventive Medicine Corp.

The Human uPTM3-DKD ELISA is a colorimetric immunoassay intended for quantitative measurement of unique Fetuin-A with specific post translational modification (PTM) in human urine and should be performed at qualified clinical laboratories by certified medical professionals, such as Medical Technologists. This product is for in vitro diagnostic use as an aid in risk assessment of renal complications in diabetic patients. Furthermore, the uPTM3-DKD test could also be applied to accurately differentiate progressive decliners of renal function in type 2 diabetes with microalbuminuria.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).