Serotonin Urine ELISA

Primary DI

04049325030619

Basic UDI-DI Code

4049325IVR06080008BU4

Reference

30192571

Device Types

Single use New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

Enzyme immunoassay for the quantitative determination of Serotonin in human urine. The assay aids in the diagnosis of depression (associated with decreased levels of serotonin). Patient population includes adults suspected to be affected by depression. The assay should not be performed with patient samples that might be affected by interference from serotonin-rich and tryptophan-rich food or samples that might be affected by drugs that interact with serotonin metabolism (such as serotonin reuptake inhibitors). The Serotonin Urine ELISA is not intended to be used as an aid in diagnosis for carcinoid syndrome. The test kit is intended for professional use only. The test kit is not for self-testing. The Serotonin Urine ELISA is not intended for near patient testing. The assay is adaptable by laboratory personnel to automate on open ELISA based liquid handler platforms; however, the programming of the steps and timing required by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory.

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