Testosterone Saliva Luminescence Immunoassay

Primary DI

04049325030473

Basic UDI-DI Code

4049325IVR06080007BTZ

Reference

30191569

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The Testosterone Saliva Luminescence Immunoassay is intended for the quantitative measurement of testosterone in saliva in adults. Measurement of testosterone has been shown to be useful in the evaluation of hormone imbalance that results in various clinical conditions like hypogonadism (androgen deficiency) in men and hypergonadism (excess of androgen hormones) e.g. polycystic ovaries in women. Use of non-invasive sample types from saliva make the test suitable for frequent sampling and testing of testosterone levels. The Testosterone Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiter plate 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 layperson use. The device is not intended for point-of-care settings.

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).