MultiSure GK

Primary DI

D-47136487612A05V

Basic UDI-DI Code

B-47136487612A05V

Reference

S84005

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Apex Biotechnology Corp.

The MultiSure GK Blood Glucose and Ketone Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm, and blood ketone in venous whole blood or capillary whole blood from fingertips. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). The system is intended for selftesting by people with diabetes or for clinical settings by healthcare professionals, as an aid in monitoring blood glucose level and blood ketone level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes or for neonatal use.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).