Free Testosterone ELISA

Primary DI

04049325030695

Basic UDI-DI Code

4049325IVR06080015BTY

Reference

DB52181

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

IBL International GmbH

The Free Testosterone ELISA is intended for the measurement of free testosterone in serum in adults. Measurement of free testosterone is an aid in diagnosis 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. The Free Testosterone 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 like Evolyzer or DSX; 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 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 Free Testosterone ELISA is NOT intended for point-of-care settings.

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