17beta-Estradiol Saliva Luminescence Immunoassay

Primary DI

04049325030534

Basic UDI-DI Code

4049325IVR06080011BTL

Reference

RE62141

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The 17beta-Estradiol Saliva Luminescence Immunoassay is intended for the measurement of 17-beta-Estradiol in human saliva. Estradiol is the most important natural estrogen and present in both women and men. The measurement of the hormone level is useful for detection of estrogen deficiency. Estradiol has an impact on puberty, primary and secondary amenorrhea and menopause. This test is not intended for assessing placental function in complicated pregnancy. Additonal hormone assays are recommended for an interpretation of the estradiol level. The 17beta-Estradiol Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiterplate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence 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 by trained personnel. The test kit is not for home or lay person use. The test kit is intended for manual use.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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