JS100 Blood Glucose Monitoring System (Standard Plus) (CE)

Primary DI

04719869704115

Basic UDI-DI Code

B-04719869704115

Reference

JS100

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Tyson Bioresearch, Inc.

The JS100 Blood Glucose Monitoring System is intended for use in the quantitatively measurement of glucose (sugar) in venous blood and fresh capillary whole blood. Capillary whole blood may be drawn from the fingertip, palm and the forearm. It is not intended for neonatal testing. The JS100 Blood Glucose Test Strips are for testing outside the body (in vitro diagnostic use). The JS100 Blood Glucose Monitoring System is intended for use at home (Over the Counter [OTC]) by persons with diabetes, or in clinical setting by healthcare professionals as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady state blood glucose conditions. [EN] [EN]

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