sInterleukin-2-Receptor ELISA

Primary DI

04049325033320

Basic UDI-DI Code

4049325IVR05060003BS8

Reference

30201813

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The sInterleukin-2-Receptor ELISA is intended for the quantitative determination of human soluble IL-2 receptor (sIL-2R) in serum and plasma (EDTA, citrate, heparin). sIL-2R levels can be used as physiological marker for the indication of inflammation in the body, in-vivo immune system activation and response activity. As such the measurement of sIL-2R levels is applied as an aid in the diagnosis or monitoring of therapy of autoimmune diseases (e.g. sarcoidosis). The sinterleukin-2-Receptor ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the on the sandwich principle measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges). The test kit is intended for manual use and can be adapted to different ELISA processors like EVOlyzer. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for self-testing. The sInterleukin-2-Receptor ELISA is NOT intended for near-patient testing.

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