Diagnostic Kit for Free T4 (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521000624

Basic UDI-DI Code

B-06974521000624

Reference

SUPF029025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for quantitative determination of free thyroxine (FT4) in human serum, plasma or whole blood samples. The test is used as an aid to the assessment of thyroid function. The thyroid hormone thyroxine (T4) is physiologically part of the regulating circuit of the thyroid gland and has an effect on general metabolism. The major fraction of the total tetraiodothyroxine is bound to transport proteins (TBG, prealbumin, and albumin). The free thyroxine (FT4) is the physiologically active thyroxine component. The determination of free thyroxine is an important element in clinical routine diagnostics. Free T4 is measured together with TSH when thyroid function disorders are suspected. The determination of FT4 is also suitable for monitoring thyroid suppressive therapy. The determination of FT4 has the advantage of being independent of changes in the concentrations and binding properties of the binding proteins; additional determination of a binding parameter (T-uptake, TBG) is therefore unnecessary. A variety of methods are available for estimating the free thyroid hormone levels. The direct measurement of FT4 and FT3 via equilibrium dialysis or ultrafiltration is mainly used as a reference method for standardizing the immunological procedures generally used for routine diagnostic purposes.

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