UASure II

Primary DI

D-47136487605AUT3F

Basic UDI-DI Code

B-47136487605AUT3F

Reference

S5640955, S5640956

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 Test Strips is intended to be used with the UASure II Link Blood Uric Acid Monitoring System/UASure II Blood Uric Acid Monitoring System to quantitative measurement uric acid level in fresh capillary whole blood from fingertips. The UASure II Link 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 Link 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 Link 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).