Neopterin ELISA

Primary DI

04049325030664

Basic UDI-DI Code

4049325IVR05060001BS2

Reference

RE59321

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The Neopterin ELISA is intended for the quantitative determination of Neopterin in human serum, plasma (EDTA) and urine in adults. Elevated neopterin levels can be measured as physiological marker for the indication of inflammation in the body, immune system activation and response activity. Neopterin is an unspecific marker for immune activation or other disturbances of the immune system and can be applied as an aid for early diagnosis of immune reaction like viral infection or allograph rejection. The Neopterin ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and 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 Thunderbolt, DSX and BEP2000. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for self-testing. The Neopterin 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).