Melatonin-Sulfate Urine ELISA

Primary DI

04049325030602

Basic UDI-DI Code

4049325IVR06080012BTP

Reference

RE54031

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Enzyme immunoassay for the quantitative determination of Melatonin Sulfate in human urine. Quantification of melatonin sulfate indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. Patient population includes healthy adults and adults suspected to be affected by sleep disorders. The assay should not be performed with patient samples that might be affected by interference from exogenous melatonin or samples that might be affected by drugs that interact with melatonin metabolism. The Melatonin-Sulfate Urine 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 manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e., normal ranges). The test kit is intended for professional laboratory use only. The test kit is not for self-testing. The Melatonin-Sulfate Urine 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).