GlucoSure Autocode

Primary DI

D-47136487601AT7P

Basic UDI-DI Code

B-47136487601AT7P

Reference

S5636096, S5640087, S5640249, S5640809, S5640259, S5636097, S5640088, S5640808, S5640751, S5640887, S5641016, S5641017

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Apex Biotechnology Corp.

The GlucoSure AutoCode Blood Glucose Test Strips are to be used with the GlucoSure AutoCode Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The GlucoSure AutoCode Blood Glucose Monitoring System is plasmacalibrated for easy comparison to lab results. It is intended for self-testing by persons with diabetes and by health care professionals. It is not indicated for the 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).