Melatonin direct Saliva ELISA

Primary DI

04049325030589

Basic UDI-DI Code

4049325IVR06080013BTS

Reference

RE54041

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Enzyme immunoassay for the direct quantitative determination of Melatonin in human saliva. Quantification of melatonin indicates physiological functions or states of the pineal gland that regulates sleep-wake cycles. This test is applied as an aid for the diagnosis of sleep disorders. Patient population includes healthy individuals and individuals 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 test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or lay person use. The test kit is intended for manual use or can be adapted to different open platform ELISA processors and can be applied to open automated platforms.

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