DHEA Saliva ELISA

Primary DI

04049325006225

Basic UDI-DI Code

4049325IVR06080000BTC

Reference

RE52651

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The DHEA Saliva ELISA is intended for the quantitative measurement of the DHEA hormone secreted by the adrenal gland using human saliva sample from adult patients. This test is intended for the measurements of DHEA levels as a physiological marker as an aid in the diagnosis and treatment of suspected dysfunction of the adrenal gland, in conjunction with other clinical parameters, such as Cortisol and other hormones. The information in addition to other clinical observations and diagnostic test is useful in assessing the level of adrenal function as a determination of physiological status in aging adults. Measurement of DHEA levels together with other hormones has been shown to be useful in the evaluation of hormone imbalance that results in various clinical conditions like hyperandrogenism (excess of androgen hormones),e.g. polycystic ovary syndrome (PCOS). Use of non-invasive sample types from saliva make the test suitable for frequent sampling and testing of DHEA levels. The DHEA Saliva ELISA is NOT appropriate for use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas. The DHEA Saliva 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. 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.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 by trained personnel.The test kit is not for home or lay person use.

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