KETOSURE POC

Primary DI

D-47136487609B06U

Basic UDI-DI Code

B-47136487609B06U

Reference

S11015

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Apex Biotechnology Corp.

The KETOSURE POC blood ketone monitoring system is intended to quantitatively measure blood ketone level in venous whole blood or fresh capillary whole blood drawn from fingertips. The KETOSUR POC blood ketone monitoring system is intended for testing outside the body (in vitro diagnostic use). It is intended for use by healthcare professionals in laboratories such as physician office laboratories, clinics, and hospitals, as an aid in monitoring blood ketone level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes.

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