T4 CLIA Microparticles

Primary DI

06970150907952

Basic UDI-DI Code

697015090000002GL

Reference

CME0201

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Autobio Diagnostics Co., Ltd.

The T4 CLIA Microparticles assay is a chemiluminescent microparticle immunoassay (CLIA Microparticles) for the quantitative determination of thyroxine (T4) in human serum. The measurement of T4 is used in the aid of diagnosis of thyroid disorders. Clinical determination of T4 is used as an aid to diagnose hypothyroidism, hyperthyroidism, to evaluate the effectiveness of treatment of thyroid diseases, and to identify, diagnosis and exclusion of self-thyroid diseases.

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).