Testo Assay kit CLIA

Primary DI

06974521004448

Basic UDI-DI Code

B-06974521004448

Reference

SUPM063036

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of testosterone (Testo) in human serum and (or) plasma. The molecular weight of Testo, which is male sex hormone, is 288 Dalton. Testo of men is almost synthesized by leydig cells. Secretion is regulated by luteinizing hormone (LH) and give negative feedback to affect the regulatory mechanism of hypophysis-hypothalamus. Testo promotes to form men's secondary sex characteristic and maintain the functions of prostate gland and seminal vesicle. Most Testo in blood circulation binds to carrier protein (such as sex hormone binding globulin (SHBG)). Women's ovary can produce a little Testo. Androgen of physiological concentration has no special effect on women. A rise in women's androgen level may result in virilism (determined by increase in the androgen level). Testing women's Testo content is helpful for diagnosis of androgen syndrome (AGS), polycystic ovary (Stein-Leventhal syndrome), as well as suspected ovarian tumor, adrenal tumor, adrenal hypoplasia or ovarian dysfunction. Testing men's Testo content is helpful for diagnosis of diseases caused by Testo deficiency, such as germinal aplasia, estrogen therapy, chromosome abnormality (such as Klinefelter syndrome) and liver cirrhosis.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).