VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Primary DI

D-01A0212Y2

Basic UDI-DI Code

B-01A0212Y2

Reference

4B001

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Changsha Sinocare Inc.

The SPUG Blood Glucose and Uric Acid Monitoring System is designed for the quantitative measurement of glucose and uric acid in fresh capillary whole blood samples and in venous whole blood samples. The blood glucose and uric acid monitoring system is for use outside the body only (in vitro diagnostic use) for self-testing or professional use as an aid in the management of diabetes and hyperuricemia(HUA). The SPUG Blood Glucose and Uric Acid Monitoring System is intended for in vitro diagnostic use and should not be used for the diagnosis of or screening of diabetes and hyperuricemia(HUA).

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