UASure II

Primary DI

D-47136487605A065

Basic UDI-DI Code

B-47136487605A065

Reference

S95050, S95056, S95055, S95057

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Apex Biotechnology Corp.

The UASure II Blood Uric Acid Monitoring System is intended for automated and quantitative measurements of blood uric acid level in fresh capillary whole blood drawn from fingertips. The UASure II Blood Uric Acid Monitoring System includes UASure II Meter, UASure II Blood Uric Acid Test Strips, and UASure II Uric Acid Control Solution. The UASure II Blood Uric Acid Monitoring System is intended for outside the body testing (in vitro diagnostic) on multiple patients by healthcare professionals in the clinical settings; and testing by a person with Hyperuricemia at home.The UASure II Blood Uric Acid Monitoring System is intended as an aid to monitor blood uric acid level, not to diagnose Hyperuricemia or Gout.The test results obtained from using the UASure II Blood Uric Acid Monitoring System should not be used as a basis to alter medications without first consulting with a physician or a healthcare professional.

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